Crise global da atenção primária à saúde / Global crisis in primary health care / Crisis global de la atención primaria

Enquanto no Norte Global se discute uma crise na Atenção Primária à Saúde, a maioria dos países nunca chegou a constituir sistemas de saúde baseados propriamente numa atenção primária robusta. Nesse cenário, o Brasil apresenta uma tendência mais favorável, com conquistas importantes para a atenção primária e a medicina de família e comunidade nos últimos dez anos. Restam desafios a serem superados para que o Sistema Único de Saúde alcance níveis satisfatórios de acesso a seus serviços, com profissionais adequadamente formados e valorizados pela população.

While the Global North is discussing a crisis in primary health care, the majority of countries have never managed to establish health systems based on robust primary care. Brazil presents a more favorable trend, with important achievements for primary care and family practice over the last ten years. There are still challenges to be overcome so that the Unified Health System achieves satisfactory levels of access to its services, with professionals who are properly trained and valued by the public.

Mientras que en el Norte Global se habla de una crisis de la atención primaria, la mayoría de los países nunca han creado realmente sistemas sanitarios basados en una atención primaria robusta. Brasil, muestra una tendencia más favorable, con importantes logros para la atención primaria y la medicina familiar y comunitaria en los últimos diez años. Aún quedan retos por superar para que el Sistema Único de Salud alcance niveles satisfactorios de acceso a sus servicios, con profesionales debidamente formados y valorados por la población.

In vitro assessment of the Kirpa Kit™ modified manual single lumen alternating micro-batch (mSLAMB) dialysis device.

BACKGROUND: Access to pediatric dialysis is challenged in low-resource settings due to high costs, scarcity of equipment, and the lack of qualified personnel availability. We demonstrated the manual single lumen alternating micro-batch (mSLAMB) device can remove small solutes in vitro without the need for electricity, batteries, or pumps. We developed a new version (Kirpa Kit™) to address some of the technical limitations of mSLAMB. Here, we compare the in vitro clearance performance and ease of use of the Kirpa Kit™ with that of prior mSLAMB configurations. METHODS: A mixture of expired packed red blood cells, 0.9% NaCl, urea, and heparin was used to test the efficiency of two mSLAMB configurations and the Kirpa Kit™ in removing potassium and urea. Clearance was evaluated by measuring percent reduction after 25-min sessions with each device. A survey was used to evaluate the ease of use of each configuration. RESULTS: The Kirpa Kit™ achieved a median urea reduction of 82.4% and potassium reduction of 82.1%, which were higher than those achieved with the best-performing mSLAMB configuration (urea 71.9%, potassium 75.4%). The Kirpa Kit™ was easier to use with a shorter perceived time of use than the mSLAMB. CONCLUSIONS: The Kirpa Kit™, evolution of mSLAMB, is easy to use and may have improved efficacy, making it an optimal candidate for in vivo testing.

Comprehensive evaluation of global health cities development levels.

Introduction: How to scientifically assess the health status of cities and effectively assist in formulating policies and planning for health city development remains a profound challenge in building a global "health community." Methods: This study employs the Building Research Establishment's International Healthy Cities Index (BRE HCI), encompassing ten environmental categories and fifty-eight indicators, to guide and support the scientific development of healthy cities. The entropy weight-TOPSIS method and the rank sum ratio (RSR) method were applied to comprehensively rank and categorize the health development levels of fifteen global cities. Furthermore, through cluster analysis, this research identifies universal and unique indicators that influence the development of healthy cities. Results: The results indicate that: (1) Within the scope of 58 evaluation indicators, the precedence in weight allocation is accorded to the kilometres of bicycle paths and lanes per 100,000 population (0.068), succeeded by m2 of public indoor recreation space per capita (0.047), and kilometres of bicycle paths and lanes per 100,000 population (0.042). (2) Among the ten environmental categories, the top three in terms of weight ranking are transport (0.239), leisure and recreation (0.172), and resilience (0.125). Significant disparities exist between different cities and environmental categories, with the issue of uneven health development within cities being particularly prominent. (3) The study categorizes the development levels of healthy cities into three tiers based on composite scores: it classifies Singapore, Shanghai, and Amsterdam at an excellent level; places Dubai and Johannesburg at a comparatively poor level; and situates the remaining ten cities at a moderate level. (4) The analysis identifies 53 international common indicators and 5 characteristic indicators from the 58 indicators based on the significance of the clustering analysis (p < 0.05). Discussion: The study proposes four strategic recommendations based on these findings: establishing a comprehensive policy assurance system, refining urban spatial planning, expanding avenues for multi-party participation, and augmenting distinctive health indicators. These measures aim to narrow the developmental disparities between cities and contribute to healthy global cities' balanced and sustainable growth. However, due to existing limitations in sample selection, research methodology application, and the control of potential confounding variables, further in-depth studies are required in the future.

Securing the rights and health of domestic workers: the importance of ratifying the ILO's C189.

This commentary highlights the critical importance of ratifying the International Labour Organization's (ILO) Domestic Workers Convention No. 189-2011 (C189) to secure the rights and health of domestic workers (DWs) worldwide, particularly in light of the World Health Organization's World Health Day 2024 theme 'My Health, My Right'. The ILO's C189 represents a significant advancement in labour rights, offering protection to a highly feminised sector where women make up 80% of the estimated 50-100 million DWs worldwide. The ILO's C189 aims to address the marginalisation and exploitation that DWs have historically faced by ensuring that they receive the same protections as other workers. This encompasses measures against abuse, harassment and violence, and the establishment of a secure and healthy working environment, as outlined in Article 13. The commentary emphasises the urgent need for the enactment of legal frameworks in countries such as Indonesia, where many of the approximately 10 million DWs encounter shocking abuses both within the country and abroad. The ratification of the C189 and the enactment of national laws, such as Indonesia's Draft Law on the Protection of Domestic Workers (RUU PPRT), are essential for the safeguarding of the rights and health of DWs. The commentary compares Indonesia with the Philippines, as the latter has been a signatory to the C189 since 2012 and has enacted its National Domestic Workers Act in 2013. The ratification of the C189, therefore, is imperative for igniting the protection and advancement of labour rights for DWs globally. This ILO's C189 represents a significant first step in addressing the long-standing and complex issues of marginalisation and exploitation prevalent in this predominantly female sector. It is also essential that the potential obstacles and concerns related to the ratification and implementation of the ILO's C189 are addressed collaboratively by stakeholders and not viewed as justifications for inaction.

Fluid and electrolyte pathophysiology in common febrile illness in children and the implications for clinical management.

Achieving fluid homeostasis and the management of fluid and electrolyte complications are constants in the treatment of seriously ill children worldwide. Consensus on the most appropriate fluid strategy for unwell children has been difficult to achieve and has evolved over the last two decades, most notably in high-income countries where adverse events relating to poor fluid management were identified more readily, and official robust inquiries were possible. However, this has not been the situation in many low-income settings where fluids that are prohibited from use in high-income countries may be all that are available, local guidelines and processes to recognise adverse events are not developed, and there has been limited training on safe fluid management for front-line healthcare workers. This narrative review outlines the fluid and electrolyte pathophysiology of common febrile illnesses in children, describes the evolution of this field and concludes with implications and principles of a fluid management strategy for seriously ill children. This review was prepared as a physiological background paper to support evidence presented to the WHO Guideline Development Group for Fluid Guidelines in Children, Geneva, March 2024.

Global associations between the use of basic drinking water and sanitation services with diarrhoeal disease incidence in 200 countries and territories from 2000 to 2019.

OBJECTIVES: Globally, billions of people do not have access to safely managed drinking water and sanitation services. Interventions to improve drinking water, sanitation and hygiene could reduce the incidence of diarrhoea in low- and middle-income countries. This study aimed to investigate the association between these services and the incidence of diarrhoea. STUDY DESIGN: Worldwide, ecological observational study, utilising cross-sectional data. METHODS: Data from the Global Burden of Disease Study 2019 and World Bank were used in this study. Diarrhoeal disease episodes were defined as three or more loose bowel movements within 24 h. Estimated Annual Percentage Change was used to quantify trends in disease incidence over a specific time interval. Quasi-Poisson Generalised Linear Model was introduced to analyse the influence of basic drinking water and sanitation services on the incidence of diarrhoea. Subgroup analyses were carried out to determine potential variations in the incidence of diarrhoeal diseases according to sex, age and sociodemographic index (SDI) region. RESULTS: Between 2000 and 2019, the incidence rate of global diarrhoea remained consistent, with regional variations linked to SDIs. A 1% increase in access to basic drinking water was associated with a 0.41% (95% confidence interval [CI], 0.33%-0.50%) increase in the age-standardised incidence rate of diarrhoea; meanwhile, a 1% increase in sanitation service usage was associated with a 0.47% (95% CI, 0.40%-0.54%) reduction in the age-standardised incidence rate of diarrhoea. The correlation differed across SDI regions. The use of safely managed drinking water was associated with a reduction in diarrhoeal disease rates, but the effect was non-significant in High SDI regions. Higher diarrhoeal disease incidence was seen in younger and older populations. Individuals in the age groups 55-59 years and 10-14 years showed the greatest association of water service usage with diarrhoea, while an increase in sanitation service usage was related to decreased diarrhoea rates in most age groups, excluding children aged 5-14 years. CONCLUSIONS: Emphasising initiatives to enhance water quality, elevate the standards of drinking water safety management, and strengthening related infrastructure development in global health policies and development plans could have a positive impact on overall global health. Such comprehensive interventions have the potential to not only prevent waterborne diseases but also elevate the general health status of societies worldwide.

Piecing together Pakistan's health system and global health security.

Pakistan's health system has a critical role to play in global health security, however, it faces numerous structural and systemic challenges while contributing to international health efforts. Understanding the dynamics of health system is essential for developing effective strategies to prevent, detect, and respond to health emergencies, ensuring regional stability, and the overall global health security This paper documents the strengths and weaknesses of Pakistan's health systems, the impact of the COVID-19 pandemic, challenges such as funding constraints and fragmented healthcare delivery, threats including antimicrobial resistance, and the importance of international collaboration. Anti-microbial particularly multi-drug resistance, food safety in emergencies, surge capacity of the frontline workforce, patient safety at the health care facilities to curtail healthcare associated infections, and strengthening the points of entry are still the areas that need special attention. To optimise the system's performance, governance and accountability mechanisms are necessary to be put in place under the auspices of national public health agency. Pakistan has the potential to transform its health system by addressing these critical areas and improve its preparedness and readiness for any future health emergency of this scale.

Diagnostic Overshadowing of Chronic Hepatitis C in People With Mental Health Conditions Who Inject Drugs: A Scoping Review.

Diagnostic overshadowing refers to a phenomenon whereby people with mental health conditions encounter inadequate or delayed medical attention and misdiagnosis. This occurs when physical symptoms are mistakenly attributed to their mental health condition. This paper presents a scoping review focusing on direct causes and background factors of diagnostic overshadowing in the context of hepatitis C infection in people who inject drugs and have concurrent mental health conditions. Despite significant strides in hepatitis C treatment with direct-acting antiviral drugs, the complex interplay of mental health conditions and physical symptoms necessitates a nuanced approach for accurate diagnosis and effective screening. This review was conducted using Joanna Briggs Institute's methodology for scoping reviews. The databases searched included Medline, Embase, PsycInfo, Global Health, CINAHL and Scopus. This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). The search strategies identified 1995 records. Overall, 166 studies were excluded. Forty-two (42) studies met the inclusion criteria. Three (n = 3) studies represented direct causes, and 39 (n = 39) with background factors related to diagnostic overshadowing. Studies highlighted six key themes encompassing diagnostic overshadowing, with communication barriers, stigma and knowledge deficiencies being the most prominent. Recognising and addressing diagnostic overshadowing in chronic hepatitis C will lead to increased screening, diagnosis and timely administration of life-saving antiviral therapy, resulting in profound enhancements in well-being and health outcomes. Moreover, this proactive approach will play a pivotal role in advancing the global effort towards eliminating hepatitis C by 2030.

Measuring availability of and facility readiness to deliver comprehensive abortion care: experiences and lessons learnt from integrating abortion into WHO's health facility assessments.

Routine assessment of health facility capacity to provide abortion and post-abortion care can inform policy and programmes to expand access and improve quality. Since 2018, abortion and/or post-abortion care have been integrated into two WHO health facility assessment tools: the Service Availability and Readiness Assessment and the Harmonised Health Facility Assessment. We discuss lessons learnt through experiences integrating abortion into these standardised tools. Our experiences highlight the feasibility of including abortion in health facility assessments across a range of legal contexts. Factors facilitating the integration of abortion include cross-country collaboration and experience sharing, timely inputs into tool adaptations, clear leadership, close relationships among key stakeholders as in assessment coordination groups, use of locally appropriate terminology to refer to abortion and reference to national policies and guidelines. To facilitate high-quality data collection, we identify considerations around question sequencing in tool design, appropriate terminology and the need to balance the normalisation of abortion with adequate sensitisation and education of data collectors. To facilitate appropriate and consistent analysis, future work must ensure adequate disaggregation of recommended and non-recommended abortion methods, alignment with national guidelines and development of a standardised approach for measuring abortion service readiness. Measurement of abortion service availability and readiness should be a routine practice and a standardised component of health facility assessment tools. Evidence generated by health facility assessments that include abortion monitoring can guide efforts to expand access to timely and effective care and help normalise abortion as a core component of sexual and reproductive healthcare.

Integrating multi-wet laboratory diagnostics to study staphylococci in animals in Uganda.

BACKGROUND: Several diagnostic environments in Uganda lack real-time, robust and high-throughput technologies for comprehensive typing of microbes, which is a setback to infectious disease surveillance. This study combined various wet laboratory diagnostics to understand the epidemiology of pathogenic staphylococci isolated from animals in Uganda and the implications for global health security priorities. METHODS: A retrospective study was conducted employing records and pathogenic staphylococci (from animals) archived at the Central Diagnostic Laboratory (CDL), Makerere University, Uganda, between January 2012 and December 2019. The bacteria were speciated by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) and tested for virulence factors [beta lactamases, lecithinase, deoxyribonuclease (DNase), haemolysins] and resistance to ten antimicrobials of clinical and veterinary relevance. Tetracycline and methicillin resistance genes were also tested. RESULTS: The prevalent diseases were mastitis in cattle and skin infections in dogs. Of the 111 staphylococci tested by MALDI-TOF MS, 79 (71.2%) were Staphylococcus aureus, 27 (24.3%) were Staphylococcus pseudintermedius and 5 (4.5%) were Staphylococcus schleiferi. All these strains expressed haemolysins. The prevalence of strains with lecithinase, penicillinase, cephalosporinase and DNase was 35.9% (14/39), 89.7% (35/39), 0.0% (0/39) and 87.2% (34/39), respectively. Staphylococci were primarily resistant to early penicillins (over 80%), tetracycline (57.7%), and chloramphenicol (46.2%). Minimal resistance was noted with cloxacillin (0.0%), ciprofloxacin (9.6%), and cefoxitin (3.8%). The prevalence of multidrug resistance (MDR) was 78.8% for general staphylococci, 82.2% for S. aureus, 73.1% for S. pseudintermedius, and 60.0% for S. schleiferi. Multidrug resistant staphylococci were significantly more prevalent in the cattle isolates than in the dog isolates (P < 0.05). The prevalence of methicillin-resistant staphylococci (MRS) tested by resistance to cefoxitin and mecA carriage was 3.8%. These four strains were all isolated from dog skin infections. The tetK gene was the most predominant (35.4%), followed by tetM (25.0%). CONCLUSION: In resource-constrained settings, the approach of integrated diagnostics promises sustainable disease surveillance and the addressing of current capacity gaps. The emergence of MRS (zoonotic bacteria) in companion animals creates a likelihood of reduced treatment options for related human infections, a threat to global health.

Beyond the Horizon: A Comprehensive Review of Contemporary Strategies in Sepsis Management Encompassing Predictors, Diagnostic Tools, and Therapeutic Advances.

This comprehensive review offers a detailed exposition of contemporary strategies in sepsis management, encompassing predictors, diagnostic tools, and therapeutic advances. The analysis elucidates the dynamic nature of sepsis, emphasizing the crucial role of early detection and intervention. The multifaceted strategies advocate for a holistic and personalized approach to sepsis care from traditional clinical methodologies to cutting-edge technologies. The implications for clinical practice underscore clinicians' need to adapt to evolving definitions, integrate advanced diagnostic tools, and embrace precision medicine. Integrating artificial intelligence and telemedicine necessitates a commitment to training and optimization. Judicious antibiotic use and recognition of global health disparities emphasize the importance of a collaborative, global effort in sepsis care. Looking ahead, recommendations for future research underscore priorities such as longitudinal studies on biomarkers, precision medicine trials, implementation science in technology, global health interventions, and innovative antibiotic stewardship strategies. These research priorities aim to contribute to transformative advancements in sepsis management, ultimately enhancing patient outcomes and reducing the global impact of this critical syndrome.

Investigating the workforce capacity and needs for animal disease surveillance and outbreak investigation: a mixed-methods study of veterinary services in Vietnam.

The need for strengthening national capacities for disease prevention, preparedness, and response is increasingly becoming urgent. Central to this is strengthening existing systems and workforce capacity for disease surveillance and disease outbreak response. This study aimed to evaluate the national capacity and needs of veterinary services in Vietnam in animal disease surveillance and outbreak investigation skills. A cross-sectional, convergent, mixed-methods study was conducted between November 2020 and April 2021. An online questionnaire was administered to government field veterinarians, followed by descriptive and multivariable analyses to understand field capacity, specifically levels of experience in outbreak investigation and animal health surveillance. Semi-structured interviews were conducted with various stakeholders in veterinary services and interview transcripts were coded and thematically analyzed. Qualitative results were used to contextualize quantitative findings from the survey. Overall, 178 field veterinary staff completed the online survey, and 25 stakeholders were interviewed. Eighty percent of respondents reported a high priority for further training in both animal disease surveillance and outbreak investigation. Training and competence were more limited at the district and commune levels, highlighting a gap in capacity at the subnational level. Reasons included a lack of in-depth training opportunities, limited access to resources and high staff turnover. Respondents who completed postgraduate qualifications in epidemiology or Field Epidemiology Training Programs were more likely to have higher levels of experience in animal health surveillance and outbreak investigation. This study identified gaps in knowledge and adoption of practices most often related to local-level or less experienced veterinary staff with limited training opportunities in epidemiology. Findings inform the prioritization of training and planning activities to further enhance the national capacity of veterinary services in Vietnam. Underlying explanations for existing gaps in capacity include inequities in skill development and training opportunities across levels of veterinary staff, gaps in the chain of command and unequal funding across provinces.

Enhancing Perspective in Global Health: A Case Study on an International Ophthalmology Partnership.

Introduction: Global ophthalmology opportunities are becoming increasingly popular, and international partnerships are becoming more common among academic training institutions in the United States. There is need for training in the complex relational, motivational, ethical, and logistical issues that may arise in these partnerships. Methods: We developed a 3-hour case-based session featuring four characters in a fictitious international ophthalmology partnership scenario. Facilitators used structured questions for each of the four parts to foster interaction and discussion among learners. After the activity, participants completed an evaluation/questionnaire consisting of Likert-scale and open-ended questions. Results: A total of 23 ophthalmology residents and seven medical students underwent the activity over four iterations. The activity was well received, with 100% of learners either strongly agreeing (90%) or agreeing (10%) when asked if the session was worthwhile and 100% of learners either strongly agreeing (87%) or agreeing (13%) when asked if the format was conducive to achieving the learning objectives. Answers to questions on how learners would change how they practice ophthalmology in their residency and in their future careers revolved around the following topics: consideration of other perspectives, humility, self- and situational awareness, complexities of partnerships, reciprocity and exchange, importance of communication, and connection of principles between international and domestic medical practice. Discussion: While this case study explores an international ophthalmology partnership scenario, the principles and themes presented can be applicable to other fields of medicine, and can be applicable to the practice of medicine both internationally and domestically.

Identifying Barriers to the Adoption of Digital Contact Tracing Apps in England: Semistructured Interview Study With Professionals Involved in the Pandemic Response.

BACKGROUND: The NHS (National Health Service) COVID-19 app was a digital contact tracing app (DCTA) used in England in response to the COVID-19 pandemic. The aim of which was to limit the spread of COVID-19 by providing exposure alerts. At the time of the pandemic, questions were raised regarding the effectiveness and cost of the NHS COVID-19 app and whether DCTAs have a role in future pandemics. OBJECTIVE: This study aims to explore key barriers to DCTAs in England during the COVID-19 pandemic. METHODS: This is a qualitative study using semistructured video interviews conducted with professionals in public health, digital health, clinicians, health care law, and health executives who had an active role in the COVID-19 pandemic. These interviews aimed to explore the perspective of different experts involved in the pandemic response and gauge their opinions on the key barriers to DCTAs in England during the COVID-19 pandemic. The initial use of maximum variation sampling combined with a snowball sampling approach ensured diversity within the cohort of interviewees. Interview transcripts were then analyzed using Braun and Clarke's 6 steps for thematic analysis. RESULTS: Key themes that acted as barriers to DCTAs were revealed by interviewees such as privacy concerns, poor communication, technological accessibility, digital literacy, and incorrect use of the NHS COVID-19 app. Interviewees believed that some of these issues stemmed from poor governmental communication and a lack of transparency regarding how the NHS COVID-19 app worked, resulting in decreased public trust. Moreover, interviewees highlighted that a lack of social support integration within the NHS COVID-19 app and delayed app notification period also contributed to the poor adoption rates. CONCLUSIONS: Qualitative findings from interviews highlighted barriers to the NHS COVID-19 app, which can be applied to DCTAs more widely and highlight some important implications for the future use of DCTAS. There was no consensus among interviewees as to whether the NHS COVID-19 app was a success; however, all interviewees provided recommendations for improvements in creating and implementing DCTAs in the future.

Detecting sexually transmitted infections beyond the syndromic approach: lessons from a rural setting in Chiapas, Mexico.

Sexually Transmitted Infections (STIs) are a critical global health concern, with low- and middle-income countries carrying the highest burden. The development of rapid point-of-care STI tests has enabled screening in settings without laboratory access. Yet, high-need settings face unique challenges that may influence the implementation and uptake of STI screening. This piece discusses lessons learned from the implementation of STI screening in a rural, low-resource setting in Chiapas, Mexico. Despite minimal privacy and a low staff-to-patient ratio, a streamlined approach was developed to destigmatize and maximize STI screening. The clinic team developed strategies through practice, including incorporating screening into triage procedures and offering screening to family members. This protocol led to an average screening rate of 37% within three months and acceptance of screening by family units. It was observed that access to treatment was necessary to alleviate patient hesitation to screening due to fears of a positive result. As STI screening increases globally, healthcare systems must develop robust access to treatment to effectively prevent and treat STIs worldwide.

"Hope is being stirred up": Critical consciousness in gender-based violence interventions.

Gender-based violence (GBV) research in public health has historically paid close attention to gender as a system of oppression, with less attention paid to the intersections between gender and other oppressive systems such as colonialism, white supremacy, and capitalism. In 2019, we adapted and pilot-tested an individual-level evidence-based sexual violence resistance intervention for university-attending women in Eswatini. We conducted a qualitative assessment of our adapted intervention's acceptability and feasibility using a critical pedagogy lens to explore how power operated in delivering an empowerment intervention, using in-depth interviews with intervention participants and facilitators. We analyzed interview transcripts thematically guided by a critical pedagogy framework and organized emergent themes into a concept map with two primary axes: participant-researcher-driven power and proximal-distal determinants. We located participant experiences with the intervention within three quadrants defined by these axes: 1) "Prescriptive," in which the researcher or facilitator primarily controls the content and delivery, with a principal focus on proximal risk reduction strategies; 2) "Solidarity," which emphasizes fostering critical consciousness among facilitators and intervention participants through dialogue, building collective power through participant-driven discussions of individual experiences; and 3) "Liberation," in which participants critically examined the power structures that underpinned their lived experiences, and expressed a desire to transform these in ways the intervention was not designed to address. These three quadrants suggest the existence of a fourth quadrant, "paternalistic," - in which the interventionist seeks to didactically educate participants about structural drivers of their own experience. Our analysis highlights a fundamental tension in the epistemology of GBV research: While there is a clear consensus that 'empowerment' is a necessary component of successful GBV interventions, "liberatory" approaches that cede power to participants are inherently antithetical to the scripted approach typically required for consistent replication in randomized control trials or other 'gold-standard' approaches for post-positivist evidence generation.

GRADE Guidance 39: Using GRADE-ADOLOPMENT to adopt, adapt or create contextualized recommendations from source guidelines and evidence syntheses.

INTRODUCTION: The GRADE-ADOLOPMENT methodology has been widely used to adopt, adapt or de novo develop recommendations from existing or new guideline and evidence synthesis efforts. This guidance refines the operationalization for applying GRADE-ADOLOPMENT. METHODS: Through iterative discussions, online meetings and email communications, the GRADE-ADOLOPMENT Project Group drafted the updated guidance. We then conducted a review of handbooks of guideline-producing organizations, and a scoping review of published and planned Adolopment guideline projects. The lead authors refined the existing approach based on the scoping review findings and feedback from members of the GRADE Working Group. We presented the revised approach to the group in November 2022 (approximately 115 people), in May 2023 (approximately 100 people) and twice in September 2023 (approximately 60 and 90 people) for approval. RESULTS: This GRADE guidance shows how to effectively and efficiently contextualize recommendations using the GRADE-ADOLOPMENT approach by: (1) showcasing alternative pathways for starting an adolopment effort; (2) elaborating on the different essential steps of this approach, such as building on existing EtDs when available or developing new EtDs if necessary; and (3) providing examples from adolopment case studies to facilitate the application of the approach. We demonstrate how to use contextual evidence to make judgments about EtD criteria, and highlight the importance of making the resulting EtDs available to facilitate adolopment efforts by others. CONCLUSION: This updated GRADE guidance further operationalizes the application of GRADE-ADOLOPMENT based on over six years of experience. It serves to support uptake and application by end users interested in contextualizing recommendations to a local setting or specific reality in a short period of time or with limited resources.

Representation of Low- and Middle-Income Countries in CKD Drug Trials: A Systematic Review.

RATIONALE & OBJECTIVE: Almost 80% of individuals with chronic kidney disease (CKD) reside in low- and middle-income countries (LMICs) and are potentially under-represented in randomized controlled clinical trials (RCTs). We assessed the global distribution of RCTs comparing pharmacological treatments for CKD over the past two decades, as well as the magnitude and evolution of participation by LMICs. STUDY DESIGN: Systematic review. SETTING & STUDY POPULATIONS: RCTs evaluating pharmacological interventions in adults with CKD. SELECTION CRITERIA FOR STUDIES: RCTs published between 2003-2023 and indexed in MEDLINE. DATA EXTRACTION: Each trial was reviewed and extracted independently by two investigators. Disagreements were settled by consensus or a third reviewer. ANALYTICAL APPROACH: RCT participation of World Bank-defined income groups and geographic regions were described and the representation indices (RI) according to RCT participants and estimated CKD prevalences were calculated. RCTs were also categorized as global, regional, or national in scope. RESULTS: Among 7,760 identified studies, we included 1,366 RCTs conducted in 84 countries with 301,158 participants. National, regional, and global RCTs represented 85.4%, 3.5%, and 11.1% of studies, respectively. LMICs were included in 34.7% of RCTs. No RCTs included participants from low-income countries, and lower-middle-income countries participated in 13.2%. Of participants from RCTs with available information, 25.4% (n=64,843/255,237) were from LMICs. According to the RI, six LMICs were over-represented (>1.25), seven adequately represented (0.75-1.25), and 26 under-represented (<0.75). Most (80.2%) global CKD RCTs included LMICs; however, LMIC participants constituted only 32.9% of the global trial population. We observed a positive trend in LMIC inclusion over time, rising from 22.9% (n=71/310) in 2003-2007 to 45.5% (n=140/308) in 2018-2023. LIMITATIONS: The use of an income-group dichotomy, exclusion of non-randomized studies of intervention, and studies identified in one database. CONCLUSIONS: Despite an increase in participation over the past two decades, individuals with CKD from LMICs remain significantly under-represented in RCTs. These findings suggest that increased efforts are warranted to increase LMIC representation in pharmacological CKD RCTs.