The importance of global bioethics to paediatric health care.

The paradigm of values adopted by the global health community has a palpable, albeit often unseen, impact on patient health care. In this Viewpoint, we investigate an inherent tension in the core values of medical ethics and clinical practice that could explain why paediatric health care faces resource constraints despite compelling economic and societal imperatives to prioritise child health and wellbeing. The dominant narrative in the philosophy of medicine tends to disproportionately underscore values of independence and self-determination, which becomes problematic in the context of paediatric patients, who by their very nature epitomise vulnerability and dependence. A double-jeopardy situation arises when disadvantaged children see their inherent dependence leveraged against them. We illustrate this predicament through specific examples relating to rights and obligations and to autonomy. Alternative value perspectives-communitarianism and relational autonomy-might offer more robust protection for vulnerable children. A shift away from the dominant narrative towards a more explicit and inclusive discussion of values is necessary. Such a shift requires giving a legitimate platform to diverse perspectives, with the presumption that collective moral progress is possible; this endeavour is embodied by global bioethics. Successful implementation of global bioethics, in turn, hinges on close collaboration between practicing clinicians and bioethicists. Taking global bioethics seriously and actively pursuing collaboration could help the global health community achieve more equitable health care.

Global Neurosurgery at the 76th World Health Assembly (2023): First Neurosurgery-Driven Resolution Calls for Micronutrient Fortification to Prevent Spina Bifida.

Since 2018, a neurosurgery delegation has been actively engaged and consistently present at the World Health Assembly. Recognizing the growing impact of neurosurgical diseases, the neurosurgery delegation participated in the 76th World Health Assembly in May 2023, advocating for timely, safe, and affordable global neurosurgical care. The delegation focused on forging new collaborations, strengthening the World Health Organization-World Federation of Neurosurgical Societies official relations, and actively supporting resolutions that impact the neurosurgical patients. However, there is a long advocacy journey ahead to address unmet neurosurgical needs. Patient-centered advocacy is an inherent task of our profession and the essence of the Global Neurosurgery Bogota Declaration of 2016. The highlight of the 76th World Health Assembly was the adoption of the first neurosurgery-driven resolution calling for micronutrient fortification to prevent spina bifida and other micronutrient deficiencies. For the last 4 years, the Global Alliance for Prevention of Spina Bifida, a group spearheaded by neurosurgeons, advocated for spina bifida prevention. This Alliance collaborated with many stakeholders, notably, the Colombian government to promote the resolution: "Accelerating efforts for preventing micronutrient deficiencies and their consequences, including spina bifida and other neural tube defects, through safe and effective food fortification." This is a proud milestone for the neurosurgical profession. There are many strategies available for neurosurgeons, when working together with elected leaders, other stakeholders, and allied professionals, to implement initiatives that can prevent future cases of spina bifida and other neurological disorders and reduce the burden of neurosurgical disease.

Incorporating surgical and anesthesia care into universal health care: a national plan for the development of surgery in Madagascar.

Efforts have been made to strengthen national health systems for safe, affordable, and timely surgical, obstetric, trauma, and anesthesia (SOTA) care since 2015 when the Lancet Commission on Global Surgery (LCoGS) identified critical needs in improving access to essential surgical care for five billion people worldwide. Several governments have developed National Surgical, Obstetric, and Anesthesia Plans (NSOAPs) as a commitment to ensuring safe and accessible surgical care for all of their population. The Ministry of Public Health (MoPH) of Madagascar launched its NSOAP in May 2019, named Le Plan National de Développement de la Chirurgie a Madagascar (PNDCHM). This policy established Madagascar as the first African francophone country to define concrete objectives for the Malagasy health system to meet the targets set by the LCoGS by 2030. The PNDCHM outlined the following priorities and specific action points to be implemented from 2019 to 2023: improving technical capacity, training human resources, developing a health information system, ensuring adequate governance and leadership, offering quality care, creating specific surgical services, and financing and mobilizing resources for implementation. Challenges encountered in the process included complex coordination between different stakeholders, allocating a sufficient budget for its implementation, frequent turnover within the MoPH, and the COVID-19 pandemic. The PNDCHM is a first of its kind in francophone Africa and the many lessons learned can serve as guidance for countries aspiring to build NSOAPs of their own.

RéSUMé: Des efforts ont été déployés pour renforcer les systèmes de santé nationaux pour des soins chirurgicaux, obstétricaux, traumatologiques et anesthésiques sécuritaires, abordables et lorsque nécessaires depuis 2015, lorsque la Commission Lancet sur la chirurgie mondiale (LCoGS) a identifié des besoins critiques pour améliorer l'accès aux soins chirurgicaux essentiels pour cinq milliards de personnes dans le monde. Plusieurs gouvernements ont élaboré des Plans nationaux pour des soins en chirurgie, d'obstétrique et anesthésie (PNCOA) dans le but d'assurer des soins chirurgicaux sécuritaires et accessibles à l'ensemble de leur population. En mai 2019, le ministère de la Santé publique de Madagascar a lancé son propre PNCOA, baptisé Le Plan National de Développement de la Chirurgie à Madagascar (PNDChM). Cette politique a fait de Madagascar le premier pays africain francophone à définir des objectifs concrets pour que le système de santé malgache atteigne les cibles fixées par la Commission Lancet d'ici 2030. Le PNDChM a défini les priorités et points d'action spécifiques suivants à mettre en œuvre de 2019 à 2023 : amélioration des plateaux techniques, formation des ressources humaines, développement d'un système d'information sanitaire, bonne gouvernance et leadership, offre de soins de qualité, création de services chirurgicaux spécialisés, et financement et mobilisation des ressources pour la mise en œuvre. Les défis rencontrés dans le processus comprenaient une coordination complexe entre les différentes parties prenantes, l'allocation d'un budget suffisant pour sa mise en œuvre, un roulement fréquent au sein du ministère de la Santé publique et la pandémie de COVID-19. Le PNDChM est une première en son genre en Afrique francophone et les nombreuses leçons apprises pourront être utiles aux pays qui aspirent à élaborer leurs propres PNCOA.

Factores socioculturales de la vulnerabilidad al sobrepeso durante los primeros años de vida en México.

OBJETIVO: Analizar el rol de los factores socioeconómicos y culturales en la vulnerabilidad a la obesidad en madres y sus hijos menores de dos años, en localidades del Sur de Morelos, México. Material y métodos. Se realizó trabajo de campo y observación no participativa. Durante 2019, se aplicaron 17 entrevistas semiestructuradas a una submuestra de una cohorte. Los datos fueron ordenados y analizados con apoyo del software Atlas-Ti v. 7, usando 18 códigos libres. RESULTADOS: Factores sociales como los ingresos del hogar y los roles de género, combinados con la influencia de la parentela y las creencias sobre la preferencia de la niñez por productos ultraprocesados, predisponen la disponibilidad de bebidas y alimentos calóricos que generan vulnerabilidad a la obesidad durante la infancia temprana. La actividad eco-nómica de las madres, la participación de los padres y evitar influencia de parientes puede predisponer una mejor calidad de los alimentos y mayor actividad física. CONCLUSIONES: La baja disponibilidad de alimentos saludables, los riesgos de inseguridad alimentaria y los factores familiares y culturales, que se presentan en contextos de vulnerabilidad económica y social, incrementan la vulnerabilidad del binomio madre-hijo a la obesidad.

Predictors of Complication Following Cleft Lip and Palate Surgery in a Low-Resource Setting: A Prospective Outcomes Study in Nicaragua.

BACKGROUND: Higher rates of postoperative complication following cleft lip or palate repair have been documented in low resource settings, but their causes remain unclear. This study sought to delineate patient, surgeon, and care environment factors in cleft complications in a low-income country. DESIGN: Prospective outcomes study. SETTING: Comprehensive Cleft Care Center. PATIENTS: Candidate patients presenting for cleft lip or palate repair or revision. INTERVENTIONS: Patient anthropometric, nutritional, environmental and peri- and post-operative care factors were collected. Post-operative evaluation occurred at standard 1-week and 2-month postoperative intervals. MAIN OUTCOME MEASURES: Complication was defined as fistula, dehiscence and/or infection. RESULTS: Among 408 patients enrolled, 380 (93%) underwent surgery, of which 208 (55%) underwent lip repair (124) or revision (84), and 178 (47%) underwent palate repair (96) or revision (82). 322 (85%) were evaluated 1 week and 166 (44%) 2 months postoperatively. 50(16%) complications were identified, including: 25(8%) fistulas, 24(7%) dehiscences, 17(5%) infections. Mid-upper arm circumference (MUAC) ≤12.5 cm was associated with dehiscence after primary lip repair (OR = 28, p = 0.02). Leukocytosis ≥11,500 on pre-operative evaluation was associated with dehiscence (OR = 2.51, p = 0.04) or palate revision fistula (OR = 64, p < 0.001). Surgeons who performed fewer previous-year palate repairs had higher likelihood of palate complications, (OR = 3.03, p = 0.01) although there was no difference in complication rate with years of surgeon experience or duration of surgery. CONCLUSIONS: Multiple patient, surgeon, and perioperative factors are associated with higher rates of complication in a low-resource setting, and are potentially modifiable to reduce complications following cleft surgery.

To Retain or Resurface the Patella in Primary Total Knee Arthroplasty: A Comparative Study.

Objective To evaluate and compare clinically and functionally patients undergoing primary total knee arthroplasty (TKA) with preservation or replacement of the patella. Methods In a cross-sectional study, the functional results were evaluated and compared, using the Western Ontario and McMaster Universities (WOMAC) and Lequesne scores, of 158 patients undergoing primary TKA (162 knees); in 81 knees the patella was submitted to arthroplasty and in 81 the joint surface of the patella was preserved. Results No significant differences were identified in terms of the Lequesne score (p = 0.585), global WOMAC score (p = 0.169), nor in terms of its subdivisions regarding stiffness (p = 0.796) and functional capacity (p = 0.190). There was a significant difference only in terms of the subdivision that evaluates pain in the WOMAC score, being lower in the group undergoing patellar arthroplasty (p = 0.036). Conclusion In the present study, there was no difference in functional assessment in patients who underwent or not patellar replacement during primary knee arthroplasty surgery. However, individuals in whom the patella was preserved reported more pain.

To Retain or Resurface the Patella in Primary Total Knee Arthroplasty: A Comparative Study / Preservar ou substituir a patela durante a artroplastia total de joelho: Estudo comparativo

Abstract Objective To evaluate and compare clinically and functionally patients undergoing primary total knee arthroplasty (TKA) with preservation or replacement of the patella. Methods In a cross-sectional study, the functional results were evaluated and compared, using the Western Ontario and McMaster Universities (WOMAC) and Lequesne scores, of 158 patients undergoing primary TKA (162 knees); in 81 knees the patella was submitted to arthroplasty and in 81 the joint surface of the patella was preserved. Results No significant differences were identified in terms of the Lequesne score (p = 0.585), global WOMAC score (p = 0.169), nor in terms of its subdivisions regarding stiffness (p = 0.796) and functional capacity (p = 0.190). There was a significant difference only in terms of the subdivision that evaluates pain in the WOMAC score, being lower in the group undergoing patellar arthroplasty (p = 0.036). Conclusion In the present study, there was no difference in functional assessment in patients who underwent or not patellar replacement during primary knee arthroplasty surgery. However, individuals in whom the patella was preserved reported more pain.

Resumo Objetivo Avaliar e comparar clínica e funcionalmente pacientes submetidos a artroplastia total primária do joelho (ATJ) com preservação ou substituição da patela. Métodos Em um estudo transversal, foram avaliados e comparados os resultados funcionais, usando escores de Western Ontario and McMaster Universities (WOMAC, na sigla em inglês) e Lequesne, de 158 pacientes submetidos a artroplastia total primária o joelho (162 joelhos), sendo que em 81 joelhos a patela foi submetidaa artroplastiae em 81 a superfície articular da patela foi preservada. Resultados Não foram identificadas diferenças significativas quanto ao escore de Lequesne (p = 0,585), escore global de WOMAC (p = 0,169), nem quanto às subdivisões deste quanto a rigidez (p = 0,796) e a capacidade funcional (p= 0,190). Evidenciou-se diferença significativa apenas quanto à subdivisão que avalia a dor no escore de WOMAC, sendo menor no grupo submetido a artroplastia patelar (p = 0,036). Conclusão No presente estudo, não houve diferença na avaliação funcional em pacientes submetidos a substituição ou não da patela durante a cirurgia de artroplastia primária do joelho. Entretanto, os indivíduos nos quais a patela foi preservada relataram mais dor.

World Cleft Coalition International Treatment Program Standards.

OBJECTIVE: To present preliminary efforts to establish an internationally agreed set of minimum core practice and best practice guidelines, along with overarching principles to promote safe and comprehensive cleft care globally. DESIGN: Representatives from 6 national and international organizations collaborated to form a World Cleft Coalition. Representatives met monthly/bimonthly to compile standards for safe, comprehensive, and sustainable cleft care. Outcomes were circulated within each organization and to a small subset of external constituents for feedback. RESULTS: A series of overarching principles were established for those involved in International Cleft Treatment Programs, based on the experience of participating organizations. The overarching principles are followed by a structured and detailed Recommended Practice for Ensuring Safe, Comprehensive and Sustainable Cleft Care, which includes minimum core and best practice for the following areas: surgical safety, quality control, patient education, patient selection, patient follow-up, comprehensive care, partnership with the host nations and professionals, training and exchanges for sustainability, and local capacity building. CONCLUSIONS: Outcomes aimed to provide a working document to define core principles for safe comprehensive cleft care, while balancing various levels of resources, geographic locations, appropriately trained health care professional specialists, and training limitations. The study highlights the process and benefits to a collaborative international working group not only to establish best practice but also to solicit and engage others in discussion of their experiences with building and supporting safe, high-quality, comprehensive, sustainable, worldwide cleft care.

Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Regulatory agencies conduct GCP inspections to verify the integrity of data generated in clinical trials and to assure the protection of human research subjects, in addition to ensuring that clinical trials are conducted according to the applicable regulations. The first joint GCP workshop of the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA-UK) was held in October 2018 and provided the agencies' perspectives on the importance of data quality management practices on data integrity. Regulatory perspectives on data blinding to minimize introduction of bias, and the role of audit trails in assessing data integrity in global clinical trials were discussed. This paper summarizes considerations of both agencies on these topics, along with case examples.

Influence of Severity on Aesthetic Outcomes of Unilateral Cleft Lip Repair in 1,823 Patients.

BACKGROUND: Although efforts to improve access to care for patients with cleft lip in the developing world have grown tremendously, there is a dearth of data regarding aesthetic outcomes after cleft lip repairs in this setting. Defining severity-outcome relationships has the potential to improve efficiency of care delivery in resource-limited settings, and to improve overall results. In this study, we investigate the relationship between initial cleft lip severity and early aesthetic outcomes following surgical repair of primary unilateral cleft lip. METHODS: Using previously validated tools to assess unilateral cleft lip severity and aesthetic outcome after repair, we evaluated 1,823 consecutive patients who underwent primary unilateral cleft lip/nose (UCL/N) repair. Three separate evaluators scored each case for a total of 5,469 total independent evaluations. RESULTS: Our results show that with increasing severity of UCL/N deformity, there is a corresponding decrease in early aesthetic outcome scores. Using our results, we established normative early aesthetic outcomes following repair for each severity grade of UCL/N deformity. CONCLUSIONS: In conclusion, this study has achieved a standardized, timely, and cost-effective evaluation of 1,823 surgical cases of primary UCL/N repair. This data set provides a normal distribution of aesthetic results according to initial cleft severity and defines a standard of "expected" aesthetic results after primary UCL/N repair. Our results also show a clear correlation between initial severity and immediate aesthetic result after surgery, though we also show that excellent results are possible regardless of initial cleft severity.

[Violence and mental health issues among Mexican adolescents that have considered or attempted cross-border migration]. / Violencia y salud mental asociados a pensar o haber intentado emigrar internacionalmente por adolescentes mexicanos.

The aim of this study was to estimate the role of victimization by violence among Mexican adolescents that have considered or attempted migrating to the United States, including mental health variables (emotional self-esteem, self-esteem in school, depression, suicidal ideation, and attempted suicide) as mediators of the effects. The study used a cross-sectional design with a stratified cluster sample of 13,198 adolescents from the 2nd Mexican National Survey on Exclusion, Intolerance, and Violence in public schools in 2009. The analysis used the regression models proposed by Baron & Kenny. Prevalence of having considered or attempted cross-border migration was 23.1%. Mean age was 16.36 years. Female adolescents constituted 54.9% of the sample, and 56% were lower-income. Mental health variables that acted as partial mediators were suicidal ideation (35.9%), depression (19.2%), attempted suicide (17.7%), emotional self-esteem (6.2%), and self-esteem in school (3.4%) for moderate family violence, and emotional self-esteem (17.5%) for social rejection in school and suicidal ideation (8.1%) for physical harm in school. Female adolescents showed greater impact from mediators than men in considering or having attempted cross-border migration. The study discusses the importance of incorporating the prevention of violence in the social contexts studied here and incorporating mental health in dealing with violence in adolescents and in public health programs in transit areas for illegal migrants.

Development of a Unifying Target and Consensus Indicators for Global Surgical Systems Strengthening: Proposed by the Global Alliance for Surgery, Obstetric, Trauma, and Anaesthesia Care (The G4 Alliance).

After decades on the margins of primary health care, surgical and anaesthesia care is gaining increasing priority within the global development arena. The 2015 publications of the Disease Control Priorities third edition on Essential Surgery and the Lancet Commission on Global Surgery created a compelling evidenced-based argument for the fundamental role of surgery and anaesthesia within cost-effective health systems strengthening global strategy. The launch of the Global Alliance for Surgical, Obstetric, Trauma, and Anaesthesia Care in 2015 has further coordinated efforts to build priority for surgical care and anaesthesia. These combined efforts culminated in the approval of a World Health Assembly resolution recognizing the role of surgical care and anaesthesia as part of universal health coverage. Momentum gained from these milestones highlights the need to identify consensus goals, targets and indicators to guide policy implementation and track progress at the national level. Through an open consultative process that incorporated input from stakeholders from around the globe, a global target calling for safe surgical and anaesthesia care for 80% of the world by 2030 was proposed. In order to achieve this target, we also propose 15 consensus indicators that build on existing surgical systems metrics and expand the ability to prioritize surgical systems strengthening around the world.

The Expanding Role of Education and Research in International Healthcare.

A recent report of the Lancet Commission on Global Surgery has continued to emphasize the importance of surgery in global health. Plastic surgeons have been involved in humanitarian care of children in developing countries for many years. The ability to repair children with cleft lip and palate in resource-poor settings has made this desirable for many plastic surgeons. A number of philanthropic plastic surgery organizations arose to deal with the problem in a more structured way. Dr. Donald Laub at Stanford established Interplast (now ReSurg) in 1969. Dr. Bill and Kathy Magee established Operation Smile in 1982, and many others have followed. The unifying theme of these organizations has been the desire to provide safe and effective surgical care to children who would otherwise be forced to live out their lives with deformity. Most care has been for children with clefts, but efforts have expanded to include hand surgery and burn reconstruction. The initial effort was provided through surgical missions. A paradigm shift has occurred as sustainability and local capacity have become paramount. Education and training of local colleagues and assistance in surgical safety infrastructure are expanding the reach of plastic surgical care around the globe. The inauguration of in-country permanent surgical centers allows high-volume outcomes research, as well as unique educational collaboration between plastic surgeons of both the developed and developing world.

Inequitable Access to Timely Cleft Palate Surgery in Low- and Middle-Income Countries.

BACKGROUND: Delayed cleft palate repair has significant implications for physical, mental, and social well-being and has been suggested to lead to an increased risk of infant and under-five mortality in low- and middle-income countries (LMICs). METHODS: Using medical records from Operation Smile international programs taking place in eleven different LMICs between March and May 2014, we performed a logistic regression assessing the relationship between delayed surgery access, defined as primary palatoplasty presentation after 24 months of age, and GDP per capita across 11 countries. RESULTS: Median age of presentation ranged from 13 to 24 months in upper-middle-income countries, 17 to 35 months in lower-middle-income countries, and 14 to 66 months in low-income countries. Our analysis demonstrated a 14 % increase in the odds of late surgery [OR = 0.88 (P < 0.001)] for every 1000 USD decrease of GDP per capita. In low- and lower-middle-income countries, this relationship was even stronger, with an OR of 0.59 (P < 0.001), indicating a 70 % increase in the odds of late surgery for every 1000 USD decrease in GDP per capita. CONCLUSIONS: There is a strong negative correlation between national income status and delayed access to primary cleft palate surgery, indicating a high degree of inequity in access to surgery, particularly in low- and lower-middle-income countries. As the importance of surgery in global health is increasingly recognized, an equity perspective must be included in the global dialog to ensure that the world's poor have fair and equitable access to essential surgical care.