Operationalizing Implementation Science in Nutrition: The Implementation Science Initiative in Kenya and Uganda.

BACKGROUND: Implementation science (IS) has the potential to improve the implementation and impact of policies, programs, and interventions. Most of the training, guidance, and experience has focused on implementation research, which is only 1 part of the broader field of IS. In 2018, the Society for Implementation Science in Nutrition borrowed concepts from IS in health to develop a broader and more integrated conceptual framework, adapted to the particular case of nutrition and with language and concepts more familiar to the nutrition community: it is called the IS in Nutrition (ISN) framework. OBJECTIVE: The purpose of this research was to generate knowledge concerning challenges and strategies in operationalizing the ISN framework in low- and middle-income country (LMIC) settings. METHODS: The ISN framework was operationalized in partnership with country teams in Kenya and Uganda over a 3-y period as part of the Implementation Science Initiative. An action research methodology (developmental evaluation) was used to provide timely feedback to the country teams, facilitate adaptations and adjustments, and generate the data presented in this article concerning challenges and strategies. RESULTS: Operationalization of the ISN framework proceeded by first articulating a set of guiding principles as touchstones for the country teams and further articulating 6 components of an IS system to facilitate development of work streams. Challenges and strategies in implementing these 6 components were then documented. The knowledge gained through this experience led to the development of an IS system operational model to assist the application of IS in other LMIC settings. CONCLUSIONS: Future investments in IS should prioritize a system- and capacity-building approach in order to realize its full potential and become institutionalized at country level. The operational model can guide others to improve the implementation of IS within a broad range of programs.

Performance-Based Financing Empowers Health Workers Delivering Prevention of Vertical Transmission of HIV Services and Decreases Desire to Leave in Mozambique.

BACKGROUND: Despite increased access to treatment and reduced incidence, vertical transmission of HIV continues to pose a risk to maternal and child health in sub-Saharan Africa. Performance-based financing (PBF) directed at healthcare providers has shown potential to improve quantity and quality of maternal and child health services. However, the ways in which these PBF initiatives lead to improved service delivery are still under investigation. METHODS: Therefore, we implemented a longitudinal-controlled proof-of-concept PBF intervention at health facilities and with community-based associations focused on preventing vertical transmission of HIV (PVT) in rural Mozambique. We hypothesized that PBF would increase worker motivation and other aspects of the workplace environment in order to achieve service delivery goals. In this paper, we present two objectives from the PBF intervention with public health facilities (n=6): first, we describe the implementation of the PBF intervention and second, we assess the impact of the PBF on health worker motivation, key factors in the workplace environment, health worker satisfaction, and thoughts of leaving. Implementation (objective 1) was evaluated through quantitative service delivery data and multiple forms of qualitative data (eg, quarterly meetings, participant observation (n=120), exit interviews (n=11)). The impact of PBF on intermediary constructs (objective 2) was evaluated using these qualitative data and quantitative surveys of health workers (n=83) at intervention baseline, midline, and endline. RESULTS: We found that implementation was challenged by administrative barriers, delayed disbursement of incentives, and poor timing of evaluation relative to incentive disbursement (objective 1). Although we did not find an impact on the motivation constructs measured, PBF increased collegial support and worker empowerment, and, in a time of transitioning implementing partners, decreased against desire to leave (objective 2). CONCLUSION: Areas for future research include incentivizing meaningful quality- and process-based performance indicators and evaluating how PBF affects the pathway to service delivery, including interactions between motivation and workplace environment factors.

Capturing Changes in HIV-Infected Breastfeeding Mothers' Cognitive Processes from Before Delivery to 5 Months Postpartum: An Application of the Pile-Sorting Technique in Haiti.

BACKGROUND: The cognitive processes involved in individuals' perceptions and prioritization of information, and how these change with experience or exposure to interventions, are rarely examined in the evaluation of nutrition interventions. Exclusive breastfeeding counseling is a common infant and young-child feeding intervention and is used to promote HIV-free survival in the prevention of mother-to-child transmission programs. However, it is often designed without adequate attention to the changes in mothers' perceptions over the course of their early breastfeeding experiences. OBJECTIVE: The aim of this study was to identify HIV-infected breastfeeding mothers' cognitive structure (their organization of messages and ideas) of infant feeding messages and to characterize whether their cognitive organization of infant feeding messages changed from pregnancy through the first 5 mo postpartum. METHODS: With the use of semistructured interviews and the cognitive mapping technique of pile sorting, we interviewed 30 HIV-infected breastfeeding mothers in Port-au-Prince, Haiti. We asked them to sort and rate 18 infant feeding messages 3 times (during pregnancy, 0- to 1-mo postpartum, and 3- to 5-mo postpartum). We analyzed their responses by using multidimensional scaling, property fitting, and partition analyses. RESULTS: At all 3 visits, we found consistency in women's cognitive mapping of messages. For example, mothers consistently differentiated messages pertinent for exclusive breastfeeding compared with those that pertained to other practices. However, subtle variations in mothers' cognition over time were also evident, particularly at 0- to 1-mo postpartum, when message proximity was tightly clustered compared with the earlier and later periods. CONCLUSIONS: We conclude that mothers share a common cognitive organization of infant feeding messages and that this organization changes over time. Attention to variations in cognition can support context-sensitive, patient-centered counseling by practitioners and improve the effectiveness of nutrition interventions. Pile sorting is an efficient, systematic technique to examine cognitive processes related to health and nutrition.

Feasibility of integrating calcium and iron-folate supplementation to prevent preeclampsia and anemia in pregnancy in primary healthcare facilities in Kenya.

Calcium (Ca) supplementation to prevent preeclampsia can save maternal and newborn lives, but there are no program models for integration into existing antenatal care platforms. We used a program impact pathway model to guide the design of integrated Ca and iron-folate (IFA) supplementation in Kenya. We provided healthcare providers with job aids (posters and counseling cards), trained them on counseling techniques and supplementation guidelines, and developed behavior change materials for pregnant women (pill-taking calendars). We allocated health facilities to prescribe either 1.0 or 1.5 g/day Ca, with standard IFA. We collected implementation data from 16 facilities and 990 women. We also explored effects of supplementation on percentage of the population meeting recommended daily allowance. Supplements and job aids were available during 90% of facility spot-check episodes; calendar availability was lower (78%). Over 98% of clients received Ca and IFA supplements, but only 76% received enough Ca supplements to last between antenatal care visits. Among clients that still had pills by return date, adherence was 77% and 83% for the IFA and Ca regimen, respectively. When 1.5 g/day of Ca supplements were prescribed, over 75% of participants met recommended daily allowance. Only 54% met the recommended daily allowance when 1.0 g was prescribed. This study illustrates a systematic approach for integrating Ca supplementation into primary healthcare and demonstrates that such integration is feasible when contextual bottlenecks are addressed. Policy makers and program planners should pay attention to supply chain, healthcare worker dispensing behavior, and appropriateness of regimen for their settings.

Who knows what: An exploration of the infant feeding message environment and intracultural differences in Port-au-Prince, Haiti.

Worldwide, mothers with young children receive many messages about infant feeding. Some messages are generated by health providers and others by the households, communities, and social contexts in which women live. We aimed to determine the scope of infant feeding messages in urban Haiti and to examine intracultural differences in salience of these messages and their alignment with international guidelines. We applied the method of free listing with 13 health workers and 15 human immunodeficiency virus (HIV)-infected and 15 HIV-uninfected mothers with infants 0-6 months old at Groupe Haïtien d'Etude du Sarcome de Kaposi et des Infections Opportunistes in Port-au-Prince, Haiti. Participants listed all messages women receive about infant feeding and specifically about HIV and infant feeding. Message salience was determined by frequency of mention and recall order; messages were coded for key themes. For all groups, the World Health Organization infant feeding recommendations were salient, especially those related to exclusive breastfeeding. Messages across all groups focused on infant health outcomes, with less emphasis on maternal outcomes. Cultural beliefs were also elicited and showed higher salience for mothers than health workers, particularly for consequences of poor maternal nutrition. Health workers' free lists were poorly correlated to those of mothers, whereas those of mothers were highly correlated, regardless of HIV status. Inasmuch as many salient messages were culturally generated, and differences existed between mothers and health workers, we conclude that it is important for health workers to acknowledge the broader infant feeding message environment, and discrepancies within that environment, to address successes and failures in the messages reaching mothers, given potential consequences for mothers' breastfeeding behaviours.

A Simplified Regimen Compared with WHO Guidelines Decreases Antenatal Calcium Supplement Intake for Prevention of Preeclampsia in a Cluster-Randomized Noninferiority Trial in Rural Kenya.

Background: To prevent preeclampsia, the WHO recommends antenatal calcium supplementation in populations with inadequate habitual intake. The WHO recommends 1500-2000 mg Ca/d with iron-folic acid (IFA) taken separately, a complex pill-taking regimen. Objective: The objective of this study was to test the hypothesis that simpler regimens with lower daily dosages would lead to higher adherence and similar supplement intake.Methods: In the Micronutrient Initiative Calcium Supplementation study, we compared the mean daily supplement intake associated with 2 dosing regimens with the use of a parallel, cluster-randomized noninferiority trial implemented in 16 primary health care facilities in rural Kenya. The standard regimen was 3 × 500 mg Ca/d in 3 pill-taking events, and the low-dose regimen was 2 × 500 mg Ca/d in 2 pill-taking events; both regimens included a 200 IU cholecalciferol and calcium pill and a separate IFA pill. We enrolled 990 pregnant women between 16 and 30 wk of gestation. The primary outcome was supplemental calcium intake measured by pill counts 4 and 8 wk after recruitment. We carried out intention-to-treat analyses with the use of mixed-effect models, with regimen as the fixed effect and health care facilities as a random effect, by using a noninferiority margin of 125 mg Ca/d.Results: Women in facilities assigned to the standard regimen consumed a mean of 1198 mg Ca/d, whereas those assigned to the low-dose regimen consumed 810 mg Ca/d. The difference in intake was 388 mg Ca/d (95% CI = 341, 434 mg Ca/d), exceeding the prespecified margin of 125 mg Ca/d. The overall adherence rate was 80% and did not differ between study arms.Conclusions: Contrary to our expectation, a simpler, lower-dose regimen led to significantly lower supplement intake than the regimen recommended by the WHO. Further studies are needed to precisely characterize the dose-response relation of calcium supplementation and preeclampsia risk and to examine cost effectiveness of lower and simpler regimens in program settings. This trial was registered at clinicaltrials.gov as NCT02238704.

A framework on the emergence and effectiveness of global health networks.

Since 1990 mortality and morbidity decline has been more extensive for some conditions prevalent in low- and middle-income countries than for others. One reason may be differences in the effectiveness of global health networks, which have proliferated in recent years. Some may be more capable than others in attracting attention to a condition, in generating funding, in developing interventions and in convincing national governments to adopt policies. This article introduces a supplement on the emergence and effectiveness of global health networks. The supplement examines networks concerned with six global health problems: tuberculosis (TB), pneumonia, tobacco use, alcohol harm, maternal mortality and newborn deaths. This article presents a conceptual framework delineating factors that may shape why networks crystallize more easily surrounding some issues than others, and once formed, why some are better able than others to shape policy and public health outcomes. All supplement papers draw on this framework. The framework consists of 10 factors in three categories: (1) features of the networks and actors that comprise them, including leadership, governance arrangements, network composition and framing strategies; (2) conditions in the global policy environment, including potential allies and opponents, funding availability and global expectations concerning which issues should be prioritized; (3) and characteristics of the issue, including severity, tractability and affected groups. The article also explains the design of the project, which is grounded in comparison of networks surrounding three matched issues: TB and pneumonia, tobacco use and alcohol harm, and maternal and newborn survival. Despite similar burden and issue characteristics, there has been considerably greater policy traction for the first in each pair. The supplement articles aim to explain the role of networks in shaping these differences, and collectively represent the first comparative effort to understand the emergence and effectiveness of global health networks.

Gender perceptions predict sex differences in growth patterns of indigenous Guatemalan infants and young children.

BACKGROUND: Nearly one-half of Guatemalan children experience growth faltering, more so in indigenous than in nonindigenous children. OBJECTIVES: On the basis of ethnographic interviews in Totonicapán, Guatemala, which revealed differences in maternal perceptions about food needs in infant girls and boys, we predicted a cumulative sex difference in favor of girls that occurred at ∼6 mo of age and diminished markedly thereafter. We examined whether the predicted differences in age-sex patterns were observed in the village, replicated the examination nationally for indigenous children, and examined whether the pattern in nonindigenous children was different. DESIGN: Ethnographic interviews (n = 24) in an indigenous village were conducted. Anthropometric measurements of the village children aged 0-35 mo (n = 119) were obtained. National-level growth patterns were analyzed for indigenous (n = 969) and nonindigenous (n = 1374) children aged 0-35 mo with the use of Demographic and Health Survey (DHS) data. RESULTS: Mothers reported that, compared with female infants, male infants were hungrier, were not as satisfied with breastfeeding alone, and required earlier complementary feeding. An anthropometric analysis confirmed the prediction of healthier growth in indigenous girls than in indigenous boys throughout the first year of life, which resulted in a 2.98-cm height-for-age difference (HAD) between sexes in the village and a 1.61-cm HAD (P < 0.001) in the DHS data between 6 and 17 mo of age in favor of girls. In both data sets, the growth sex differences diminished in the second year of life (P < 0.05). No such pattern was seen in nonindigenous children. CONCLUSIONS: We propose that the differences in the HAD that first favor girls and then favor boys in the indigenous growth patterns are due to feeding patterns on the basis of gendered cultural perceptions. Circumstances that result in differential sex growth patterns need to be elucidated, in particular the favorable growth in girls in the first year of life.

Expanding the frontiers of population nutrition research: new questions, new methods, and new approaches.

Nutrition research, ranging from molecular to population levels and all points along this spectrum, is exploring new frontiers as new technologies and societal changes create new possibilities and demands. This paper defines a set of frontiers at the population level that are being created by the increased societal recognition of the importance of nutrition; its connection to urgent health, social, and environmental problems; and the need for effective and sustainable solutions at the population level. The frontiers are defined in terms of why, what, who, and how we study at the population level and the disciplinary foundations for that research. The paper provides illustrations of research along some of these frontiers, an overarching framework for population nutrition research, and access to some of the literature from outside of nutrition that can enhance the intellectual coherence, practical utility, and societal benefit of population nutrition research. The frontiers defined in this paper build on earlier forward-looking efforts by the American Society for Nutrition and extend these efforts in significant ways. The American Society for Nutrition and its members can play pivotal roles in advancing these frontiers by addressing a number of well-recognized challenges associated with transdisciplinary and engaged research.

Finding common ground: perspectives on community-based childhood obesity prevention.

To support successful and inclusive community organizing for childhood obesity prevention, this research identified stakeholder perspectives on what communities should do to prevent childhood obesity. It employed factor analysis on statement sorts (Q methodology) conducted by 95 people in an upstate New York community. These participants sorted 36 statements about the issue by how much he or she agreed or disagreed with each. Participants were recruited through strategic snowball sampling to sample a variety of perspectives. The four resulting factors, or perspectives, were interpreted in the context of presort demographic surveys and postsort interviews. This research found one stance that fits the environmental perspective common in public health. The other three factors indicate important variations among perspectives centered on individual responsibility, ranging from libertarian to technocratic views. However, overall, results revealed a substantial degree of agreement among the four perspectives, including on providing access to family activities and on making fruits and vegetables more available and affordable, for example, through subsidies. This article points to common ground for community action on childhood obesity prevention, highlights areas likely to generate considerable contention, and shows whose views are not being accounted for in, at least, this community's childhood obesity prevention project.

Nutrition agenda setting, policy formulation and implementation: lessons from the Mainstreaming Nutrition Initiative.

Undernutrition is the single largest contributor to the global burden of disease and can be addressed through a number of highly efficacious interventions. Undernutrition generally has not received commensurate attention in policy agendas at global and national levels, however, and implementing these efficacious interventions at a national scale has proven difficult. This paper reports on the findings from studies in Bangladesh, Bolivia, Guatemala, Peru and Vietnam which sought to identify the challenges in the policy process and ways to overcome them, notably with respect to commitment, agenda setting, policy formulation and implementation. Data were collected through participant observation, documents and interviews. Data collection, analysis and synthesis were guided by published conceptual frameworks for understanding malnutrition, commitment, agenda setting and implementation capacities. The experiences in these countries provide several insights for future efforts: (a) high-level political attention to nutrition can be generated in a number of ways, but the generation of political commitment and system commitment requires sustained efforts from policy entrepreneurs and champions; (b) mid-level actors from ministries and external partners had great difficulty translating political windows of opportunity for nutrition into concrete operational plans, due to capacity constraints, differing professional views of undernutrition and disagreements over interventions, ownership, roles and responsibilities; and (c) the pace and quality of implementation was severely constrained in most cases by weaknesses in human and organizational capacities from national to frontline levels. These findings deepen our understanding of the factors that can influence commitment, agenda setting, policy formulation and implementation. They also confirm and extend upon the growing recognition that the heavy investment to identify efficacious nutrition interventions is unlikely to reduce the burden of undernutrition unless or until these systemic capacity constraints are addressed, with an emphasis initially on strategic and management capacities.

The nutrition policy process: the role of strategic capacity in advancing national nutrition agendas.

Undernutrition is the single largest contributor to the burden of disease in developing countries and has documented effects on social and economic development, yet progress in reducing undernutrition remains slow. This paper identifies the range of factors that have influenced the nutrition agenda in developing countries, in order to inform the implementation of three major global initiatives related to undernutrition. Data sources include interviews with nutrition practitioners at the national and international level, written accounts from six African countries, and observations of the policy process in five countries. Data were thematically coded to identify recurrent factors that facilitated or inhibited progress in addressing undernutrition. The data reveal the following: First, societal conditions and catalytic events pose a variety of challenges and opportunities to enlarge and shape the nutrition agenda. Some countries have been successful in using such opportunities, while others have been less successful and there have been some unintended consequences. Second, disagreements over interventions and strategies are an almost universal feature of the nutrition policy process, occur primarily among mid-level actors rather than among politicians or senior administrators, and are primarily the product of structural factors such as organizational mandates, interests, and differences in professional perspectives. Third, many of these structural factors can be molded, aligned, and/or circumvented through strategic action on the part of the mid-level actors to strengthen movement on the nutrition agenda. This evidence that strategic action can redirect and/or overcome the effects of structural factors has important implications for future efforts to advance the nutrition agenda.

Bolivia's multisectoral Zero Malnutrition Program: insights on commitment, collaboration, and capacities.

A number of multilateral and bilateral food security and nutrition initiatives have been launched in the wake of the 2008 food crisis, many with the explicit intention of fostering country ownership, multisectoral action, and harmonization among international partners. These bear some resemblance to the failed multisectoral nutrition planning initiatives that followed the 1974 world food crisis, raising the question of whether the current initiatives are doomed to experience the same fate. This paper explores these questions in one country by focusing on the policy sustainability of Bolivia's Zero Malnutrition Program (ZM), a multisectoral initiative that appeared at its initiation to be buttressed by political support and strengthened by design features that differed in important ways from similar efforts of the 1970s. Retrospective and prospective data collected through an action research and grounded methodology revealed, however, that the real struggle in Bolivia came after ZM was launched. ZM champions made undeniable progress in the first 2 years of the program with health-sector interventions, but they underestimated the challenges of building and sustaining the commitment of high-level political leaders, mid-level bureaucrats, and local-level implementers in the majority of other sectors. These initial experiences from Bolivia hold important lessons for several global initiatives to scale up nutrition actions, which are being launched in great haste and so far have given scant attention to strategies for managing the nutrition policy process and strengthening the capacities for implementation.

The management of conflict in nutrition policy formulation: choosing growth-monitoring indicators in the context of dual burden.

We argue in this paper that a shared desire to find a solution to malnutrition and agreement at a broad level concerning priority, evidence-based interventions are important but not sufficient conditions for effective policy development. This paper illustrates this point, and draws out general implications, through a detailed analysis of a case in which conflict emerged when committed nutrition policy actors began discussing the details of program design and implementation. The case involves one country's effort to select "the best" anthropometric indicator for use in its national child growth-monitoring program. In this case the interested parties approached this deceptively simple decision for different reasons, using different sources and standards of evidence and focusing their attention on opposite, but equally critical, operational considerations, while being heavily influenced by global, national, and interorganizational events and relationships. We suggest that actors seeking to translate political commitment for nutrition into effective action should recognize the technical and sociopolitical complexity of seemingly simple decisions related to intervention design and employ more systematic, intentional, and inclusive decision-making procedures. Without attention to such practical matters, the current window of opportunity to reduce malnutrition on a global scale may quickly close.

The formulation of consensus on nutrition policy: policy actors' perspectives on good process.

Food security and nutrition are ascendant issues on global and national policy agendas in recent years, as a result of the global food crisis and growing recognition of the magnitude and consequences of these problems for human and economic development. The translation of this attention into effective action at the country level will require multistakeholder agreements concerning priority problems, interventions, delivery strategies, roles and responsibilities, and other matters, but this has proven to be a difficult and contentious process in many countries. This study explores stakeholders' perspectives on the characteristics of a good process in Guatemala, a country that has encountered difficulties deciding such matters in recent years, as well as their views on decision acceptance and the feasibility of implementing a good process. Semistructured interviews were conducted with 20 participants in earlier policy deliberations who were identified through snowball sampling. The constant comparative method was used for analysis. These participants attach great importance to the quality of decision processes, have strong support for decision principles derived from theory and experience elsewhere, would be willing to participate in such a process and accept the resulting decisions, and feel such a process would be challenging but feasible in the Guatemalan context. These findings, together with experiences elsewhere, suggest that countries would do well to seek agreement on the design of a multistakeholder decision-making process before they seek agreement on priority nutrition problems, target groups, interventions, delivery strategies, and other matters that have proven contentious in many settings.

Assessment of epidemiologic, operational, and sociopolitical domains for mainstreaming nutrition.

Although undernutrition impacts a range of short- and long-term outcomes, nutrition often has low priority on global and national development policy agendas because of overemphasis on technical solutions without adequate consideration of contextual and political factors. An approach is needed for strategic development of nutrition agendas that embraces the contexts influencing policy and program planning and implementation, while addressing salient causes of undernutrition. We describe a simple, comprehensive assessment approach to enable development of sound nutrition strategies and well-grounded effective and appropriate actions for nutrition in a given context. The conceptual framework for this assessment approach incorporates three domains, each essential for defining strategic actions for nutrition: epidemiologic, pertaining to the nutritional situation and the evidence about the efficacy and effectiveness of nutrition interventions; operational, pertaining to coverage, quality, and utilization of nutrition-related interventions and programs as well as capacities, opportunities, and constraints to improving these; and sociopolitical, pertaining to social, political, cultural, and organizational factors at various levels, which may enhance or inhibit efforts to create positive changes in policies and programs. The domains are interlinked, and the sociopolitical domain often underlies the other two domains. Using this framework can reveal important insights for the nutrition policy agenda that were hitherto not considered explicitly in efforts to advance nutrition. This is highlighted in an example from Vietnam and through other papers in this Supplement. Use of this three-domain assessment framework can greatly aid development of feasible and actionable nutrition strategies that are grounded in epidemiologic, operational, and sociopolitical realities.

The effect of dietary iron intake on the development of iron overload among homozygotes for haemochromatosis.

OBJECTIVE: To quantify the role of dietary Fe in total body Fe (TBI) accumulation among homozygotes for the HFE gene associated with haemochromatosis. DESIGN: A Monte Carlo model was built to simulate Fe accumulation based on findings from human feeding experiments and national dietary surveys. A hypothetical cohort of 1000 homozygotes with starting age 25 years was used in 39-year simulations. The impact of reducing dietary Fe intake on Fe accumulation was tested. RESULTS: In the baseline model without any dietary intervention, by age 64, the percentage of males with TBI > 10 g, >15 g and >20 g was 93.2%, 49.6% and 14.7%, respectively. When the Fe intake of individuals in the cohort was reduced to < or =200% of the recommended dietary allowance (RDA), the corresponding percentages were 92.0%, 40.5% and 10.2%, respectively. The corresponding figures were 91.0%, 40.0% and 9.3% for Fe defortification and 70.3%, 21.3% and 4.1% when Fe intake was capped at 100% RDA. Similar trends were seen with sexes combined, although the impact of interventions was less. Sensitivity analysis revealed that the rate of Fe accumulation and the impact of dietary interventions are highly dependent on assumptions concerning Fe absorption rates. CONCLUSIONS: Variation in Fe intake as currently observed in the USA contributes to variation in Fe accumulation among homozygotes, when continued over an extended period. Lifelong dietary habits and national fortification policy can affect the rate of Fe accumulation, although the magnitude of the effect varies by gender, the TBI level of interest and factors affecting the Fe absorption rate.

The potential effect of iron defortification on iron-deficiency anaemia in the US population.

OBJECTIVE: To quantify the potential effect of iron defortification in the USA on iron-deficiency anaemia (IDA). METHODS: Monte Carlo models were built to simulate iron nutrition in the US population. A hypothetical cohort of 15 000 persons from the general population was used in 15-year simulations to compare the prevalence of IDA with and without fortification. RESULTS: With iron fortification, the prevalence of IDA was 2.4% for children aged 3-5 years, 5.4% for women aged 20-49 years, and 0.14% for men aged 20-49 years. The corresponding IDA estimates under iron defortification were 4.5%, 8.2% and 0.46%, respectively. Defortification had little effect on the distribution of iron indicators at or above the 50th percentile within each of these three groups and little effect on the distributions of iron indicators among adult men. CONCLUSION: Iron defortification is likely to increase IDA among children and women of reproductive age, but is not likely to have meaningful effects on the iron status of men or the majority of women and children.

Science, law, and politics in FDA's genetically engineered foods policy: scientific concerns and uncertainties.

The Food and Drug Administration's (FDA's) 1992 policy statement granted genetically engineered foods presumptive GRAS (generally recognized as safe) status. Since then, divergent views have been expressed concerning the scientific support for this policy. This paper examines four sources to better understand the basis for these claims: 1) internal FDA correspondence; 2) reports from the National Academy of Sciences; 3) research funded by US Department of Agriculture from 1981 to 2002; and 4) FDA's proposed rules issued in 2001. These sources reveal that little research has been conducted on unintended compositional changes from genetic engineering. Profiling techniques now make this feasible, but the new debate centers on the functional meaning of compositional changes.