In 2021, a global tuberculosis vaccine research and development roadmap proposed a series of actions to accelerate the development of new, effective, and affordable vaccines that are urgently needed to eliminate tuberculosis globally. Since then, the pipeline has diversified, several candidates are currently in phase 3 clinical trials, and many low-income and middle-income countries have made important steps in anticipating regulatory approval. However, the number of candidates in active clinical trials is small and product development challenges persist. Engagement with vaccine manufacturers has increased but is hampered by unclear demand and insufficient committed procurement. Investment in tuberculosis vaccine research and development therefore remains risky and inadequate. In parallel, more work is needed to identify and plan for cost-effective implementation while mitigating potential hesitancy and stigma to ensure uptake of new tuberculosis vaccines once licensed. Increased diversification of funders and strategic coordination of multiple stakeholders is needed more than ever.
Background and Objective: Over the past decade substantial government and market-driven efforts focused on the use of real-world evidence (RWE) to improve healthcare decision-making. A successful strategy has been mounted by specialty societies and their registries that have created RWE through a model known as the Coordinated Registry Network (CRN), which has accelerated innovation, improved care quality, addressed the safety and efficacy of medical products, and supported medical research. This three-part manuscript works to understand how the CRNs have succeeded by applying organizational sociology and the theory of Systemic Coordinated Inter-Organizational Networks (SCIONs). Methods: We describe CRNs as organizations that evolved from the traditional registries of clinical specialty societies. We present the SCIONs theory, a network of organizations that deploy a coordination strategy based on trust and cooperation to solve complex problems. By applying sociological concepts, we identified key characteristics and functions that can inform the development of CRNs, providing practical guidance for their implementation. Results: Our analysis reveals that CRNs offer a unique mode of coordination that can address complex healthcare challenges, leveraging traditional market and government efforts. CRNs can support the vision of a learning health system and evidence-based medicine by harnessing the power of RWE, transforming, and improving healthcare delivery. Conclusion and Implications for Translation: CRNs have the potential to transform evidence generation in healthcare by curating and integrating multiple data sources that can address the data needs of multiple CRN partners. This American solution to the provision of evidence for supporting decision-making in healthcare builds on professional society relationships; the CRN model has demonstrated success in large national registries and warrants expansion to other specialty areas. By understanding the organizational sociology of CRNs, we can unlock their full potential to drive innovation, efficiency, and quality improvement in healthcare.
Background and Objective: Previous work in this series has introduced real-world evidence (RWE), coordinated registry networks (CRNs), and systemic, coordinated, inter-organizational networks (SCIONs) theory. The application of SCIONs theory to CRNs illuminates how their structure and function foster trust and cooperation in a network of organizations to successfully address complex problems in healthcare. This third part in the series asks questions about how SCIONs theory can benefit CRNs and how the experience of CRNs can further develop the SCIONs theory. Methods: This manuscript analyzes reciprocal relationships related to SCIONs theory and CRN practice, examining how each can be used to benefit the other. While SCIONs theory has not yet formally been used to direct the development of a CRN, future application is proposed. Conversely, we explored how the practical experiences of CRNs can inform and refine our understanding of SCIONs, including identifying areas for theoretical development and through an exploration of the current limitations of CRNs. Results: The SCIONs theory may usefully direct CRN development in key leadership areas, including increasing human capital, encouraging organizational adaptiveness, expanding institutional capacity, mobilizing political engagement, and generating cooperative behavior. CRNs, guided by SCIONs theory, can offer a pathway towards a more efficient, equitable, and learning-oriented healthcare system. A comprehensive approach proposed for CRNs may facilitate the expansion of the evaluation component in SCIONs theory. Conclusion and Implications for Translation: CRN program managers should prioritize strategic approaches that foster human capital, organizational adaptability, and institutional capacity. Government agencies may consider investments in CRN as a way to build RWE infrastructure that improves quality and efficiency of healthcare broadly. Public discourse may benefit from a clearer understanding of the role of cooperation in society to address issues that government and markets are not well suited to address. The literature on SCIONs can support the non-profit literature in the way the business literature supports the for-profit sector.
Background: Tuberculosis (TB) remains a major global public health problem.Early detection and initiation of treatment shortens infectious period and is key to TB control.A considerable proportion of TB patients presenting with advanced symptoms suggests delay in seeking care.As TB control programs rely on passive case finding, TB care-seeking behavior is critical as undiagnosed cases act as reservoirs for transmission.This study assessed patient health seeking behavior and choice of place of care among TB patients in Nigeria.Methods: This was a pro-gramme implementation, facility-based crosssectional study in 14 states, 92 facilities across three levels of care.Interviewer-administered semi-structured questionnaires were used.Information on personal characteristics and health seeking behavior was collected from June 2020 to December 2021.The analysis was based on the various healthcare providers where the respondents first sought care.Data analysis was done using IBM SPSS and summarized using frequency and percentages.Chi square test was used for associations of characteristics of patients and choice of place of care at p < 0.05.Results: In all 14 states, distribution of overall first place of seeking care for TB symptoms was: 7208 (75.8%) health facilities (range 57% to 88%), while 2294 (24.2%) visited other places including community pharmacist, patent medicine vendor, traditional/home, un-specified/ none.For Health facilities, the majority were at public facilities 6563 (69.1%) and private 641 (6.7%).Moreover, 6 states had >20% of respondents who first sought
ABSTRACTBackgroundPregnant women with COVID-19 are at an increased risk of severe COVID-19 illness as well as adverse pregnancy and birth outcomes. Many countries are vaccinating or considering vaccinating pregnant women with limited available data about the safety of this strategy. Early identification of safety concerns of COVID-19 vaccines, including their components, or their technological platforms is therefore urgently needed.MethodsWe conducted a rapid systematic review, as the first phase of an ongoing full systematic review, to evaluate the safety of COVID-19 vaccines in pregnant women, including their components, and their technological platforms (whole virus, protein, viral vector or nucleic acid) used in other vaccines, following the Cochrane methods and the PRISMA statement for reporting (PROSPERO-CRD42021234185).We searched literature databases, COVID-19 and pregnancy registries from inception February 2021 without time or language restriction and explored the reference lists of relevant systematic reviews retrieved. We selected studies of any methodological design that included at least 50 pregnant women or pregnant animals exposed to the vaccines that were selected for review by the COVAX MIWG in August 2020 or their components or platforms included in the COVID-19 vaccines, and evaluated adverse events during pregnancy and the neonatal period.Pairs of reviewers independently selected studies through the COVIDENCE web software and performed the data extraction through a previously piloted online extraction form. Discrepancies were resolved by consensus.ResultsWe identified 6768 records, 256 potentially eligible studies were assessed by full-text, and 37 clinical and non-clinical studies (38 reports, involving 2,397,715 pregnant women and 56 pregnant animals) and 12 pregnancy registries were included.Most studies (89%) were conducted in high-income countries. The most frequent study design was cohort studies (n=21), followed by surveillance studies, randomized controlled trials, and registry analyses. Most studies (76%) allowed comparisons between vaccinated and unvaccinated pregnant women (n=25) or animals (n=3) and reported exposures during the three trimesters of pregnancy.The most frequent exposure was to AS03 adjuvant in the context of A/H1N1 pandemic influenza vaccines (n=24), followed by aluminum-based adjuvants (n=11). Aluminum phosphate was used in Respiratory Syncytial Virus Fusion candidate vaccines (n=3) and Tdap vaccines (n=3). Different aluminum-based adjuvants were used in hepatitis vaccines. The replication-deficient simian adenovirus ChAdOx1 was used for a Rift Valley fever vaccine. Only one study reported exposure to messenger RNA (mRNA) COVID-19 vaccines that also used lipid nanoparticles. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03) - corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns.ConclusionThis rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines that were selected for review by the COVAX MIWG or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted given their novelty. Our findings support current WHO guidelines recommending that pregnant women may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.
