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Scoping review protocol on research prioritisation for preparedness and response to outbreaks of high consequence pathogens
Background: Prioritisation of research activities for infectious disease pathogens is usually undertaken through the identification of important research and knowledge gaps. Research prioritisation is an essential element of both effective responses to disease outbreaks and adequate preparedness. There is however currently no published mapping of activities on and evidence from research prioritisation for high consequence pathogens. The objectives of this review are to map all published research prioritisation exercises on high-consequence pathogens; provide an overview of methodologies employed for prioritising research for these pathogens; describe monitoring and evaluation processes for research areas prioritised; and identify any standards and guidance for effectively undertaking research prioritisation activities for high consequence pathogens. Methods: The Joanna Briggs Institute guidance of scoping review conduct will be used. The search will be undertaken using the key terms of “research prioritisation”, “response”, “control”, and related terms, and a list of high-consequence pathogens derived from WHO (2020), EMERGE (2019), Europe CDC (2022) and the Association of Southeast Asian Nations (2021). We will search WHO Global Index Medicus; Ovid Medline; Ovid Embase; Ovid Global Health; and Scopus. Backward citations review of the included full text documents will also be conducted. Google Scholar and Overton will be searched for grey literature. Two independent reviewers will screen the retrieved documents using Rayyan and extract data in a data extraction template in Microsoft Excel 2021. Screening results will be presented using the PRISMA-ScR template with narrative synthesis undertaken for the extracted data. Conclusion: This review will map existing research priorities for high consequence pathogens. Further, it will provide an understanding of methodologies used for prioritisation, processes for monitoring and evaluation of progress made against research agendas, and evidence on standards that could be recommended for effective prioritisation of research for high consequence pathogens.
Scoping review protocol on research prioritisation for preparedness and response to outbreaks of high consequence pathogens.
BackgroundPrioritisation of research activities for infectious disease pathogens is usually undertaken through the identification of important research and knowledge gaps. Research prioritisation is an essential element of both effective responses to disease outbreaks and adequate preparedness. There is however currently no published mapping of activities on and evidence from research prioritisation for high consequence pathogens. The objectives of this review are to map all published research prioritisation exercises on high-consequence pathogens; provide an overview of methodologies employed for prioritising research for these pathogens; describe monitoring and evaluation processes for research areas prioritised; and identify any standards and guidance for effectively undertaking research prioritisation activities for high consequence pathogens.MethodsThe Joanna Briggs Institute guidance of scoping review conduct will be used. The search will be undertaken using the key terms of "research prioritisation", "response", "control", and related terms, and a list of high-consequence pathogens derived from WHO (2020), EMERGE (2019), Europe CDC (2022) and the Association of Southeast Asian Nations (2021). We will search WHO Global Index Medicus; Ovid Medline; Ovid Embase; Ovid Global Health; and Scopus. Backward citations review of the included full text documents will also be conducted. Google Scholar and Overton will be searched for grey literature. Two independent reviewers will screen the retrieved documents using Rayyan and extract data in a data extraction template in Microsoft Excel 2021. Screening results will be presented using the PRISMA-ScR template with narrative synthesis undertaken for the extracted data.ConclusionThis review will map existing research priorities for high consequence pathogens. Further, it will provide an understanding of methodologies used for prioritisation, processes for monitoring and evaluation of progress made against research agendas, and evidence on standards that could be recommended for effective prioritisation of research for high consequence pathogens.
Scoping review protocol on research prioritisation for preparedness and response to outbreaks of high consequence pathogens
Background Prioritisation of research activities for infectious disease pathogens is usually undertaken through the identification of important research and knowledge gaps. Research prioritisation is an essential element of both effective responses to disease outbreaks and adequate preparedness. There is however currently no published mapping of activities on and evidence from research prioritisation for high consequence pathogens. The objectives of this review are to map all published research prioritisation exercises on high-consequence pathogens; provide an overview of methodologies employed for prioritising research for these pathogens; describe monitoring and evaluation processes for research areas prioritised; and identify any standards and guidance for effectively undertaking research prioritisation activities for high consequence pathogens. Methods The Joanna Briggs Institute guidance of scoping review conduct will be used. The search will be undertaken using the key terms of “research prioritisation”, “response”, “control”, and related terms, and a list of high-consequence pathogens derived from WHO (2020), EMERGE (2019), Europe CDC (2022) and the Association of Southeast Asian Nations (2021). We will search WHO Global Index Medicus; Ovid Medline; Ovid Embase; Ovid Global Health; and Scopus. Backward citations review of the included full text documents will also be conducted. Google Scholar and Overton will be searched for grey literature. Two independent reviewers will screen the retrieved documents using Rayyan and extract data in a data extraction template in Microsoft Excel 2021. Screening results will be presented using the PRISMA-ScR template with narrative synthesis undertaken for the extracted data. Conclusion This review will map existing research priorities for high consequence pathogens. Further, it will provide an understanding of methodologies used for prioritisation, processes for monitoring and evaluation of progress made against research agendas, and evidence on standards that could be recommended for effective prioritisation of research for high consequence pathogens.
Severe acute hepatitis of unknown aetiology in children—what is known?
AbstractThe ongoing investigations into clusters of children affected by severe acute hepatitis of unknown aetiology have put our global capacity for a coordinated, effective response to the test. The global health community have rapidly convened to share data and inform the response. In the UK, where most cases were initially identified, a coordinated public health and clinical research response was rapidly initiated. Since then, cases have been reported from other countries, predominantly from higher-income countries. While agencies are keeping an open mind to the cause, the working hypothesis and case notifications raise important questions about our capacity to detect emerging cases in lower-resourced settings with a recognised lack of access to diagnostics even for commonly circulating viruses such as hepatitis A. The limited capability to generate integrated global pathogen surveillance data is a challenge for the outbreak investigations, highlighting an urgent need to strengthen access to diagnostics, with a focus on lower-resourced settings, to improve the capacity to detect emerging diseases to inform care and to improve outcomes and outbreak control.
"As a patient I do not belong to the clinic, I belong to the community": co-developing multi-level, person-centred tuberculosis stigma interventions in Cape Town, South Africa.
BackgroundAnticipated, internal, and enacted stigma are major barriers to tuberculosis (TB) care engagement and directly impact patient well-being. Unfortunately, targeted stigma interventions are lacking. We aimed to co-develop a person-centred stigma intervention with TB-affected community members and health workers in South Africa.MethodsUsing a community-based participatory research approach, we conducted ten group discussions with people diagnosed with TB (past or present), caregivers, and health workers (total n = 87) in Khayelitsha, Cape Town. Group discussions were facilitated by TB survivors. Discussion guides explored experiences and drivers of stigma and used human-centred design principles to co-develop solutions. Recordings were transcribed, coded, thematically analysed, and then further interpreted using the socio-ecological model and behaviour change wheel framework.ResultsIntervention components across socio-ecological levels shared common functions linked to effective behaviour change, namely education, training, enablement, persuasion, modelling, and environmental restructuring. At the individual level, participants recommended counselling to improve TB knowledge and provide ongoing support. TB survivors can guide messaging to nurture stigma resilience by highlighting that TB can affect anyone and is curable, and provide lived experiences of TB to decrease internal and anticipated stigma. At the interpersonal level, support clubs and family-centred counselling were suggested to dispel TB-related myths and foster support. At the institutional level, health worker stigma reduction training informed by TB survivor perspectives was recommended to decrease enacted stigma. Participants discussed how integration of TB/HIV care services may exacerbate TB/HIV intersectional stigma and ideas for restructured service delivery models were suggested. At the community level, participants recommended awareness-raising events led by TB survivors, including TB information in school curricula. At the policy level, solutions focused on reducing the visibility generated by a TB diagnosis and resultant stigma in health facilities and shifting tasks to community health workers.ConclusionsDecreasing TB stigma requires a multi-level approach. Co-developing a person-centred intervention with affected communities is feasible and generates stigma intervention components that are directed and implementable. Such community-led multi-level intervention components should be prioritised by TB programs, including integrated TB/HIV care services.Supplementary informationThe online version contains supplementary material available at 10.1186/s44263-024-00084-z.
"This is an illness. No one is supposed to be treated badly": community-based stigma assessments in South Africa to inform tuberculosis stigma intervention design.
BackgroundThough tuberculosis (TB)-related stigma is a recognized barrier to care, interventions are lacking, and gaps remain in understanding the drivers and experiences of TB-related stigma. We undertook community-based mixed methods stigma assessments to inform stigma intervention design.MethodsWe adapted the Stop TB Partnership stigma assessment tool and trained three peer research associates (PRAs; two TB survivors, one community health worker) to conduct surveys with people with TB (PWTB, n = 93) and caregivers of children with TB (n = 24) at peri-urban and rural clinic sites in Khayelitsha, Western Cape, and Hammanskraal, Gauteng Province, South Africa. We descriptively analyzed responses for each stigma experience (anticipated, internal, and enacted), calculated stigma scores, and undertook generalized linear regression analysis. We conducted 25 in-depth interviews with PWTB (n = 21) and caregivers of children with TB (n = 4). Using inductive thematic analysis, we performed open coding to identify emergent themes, and selective coding to identify relevant quotes. Themes were organized using the Constraints, Actions, Risks, and Desires (CARD) framework.ResultsSurveys revealed almost all PWTB (89/93, 96%) experienced some form of anticipated, internal, and/or enacted stigma, which affected engagement throughout the care cascade. Participants in the rural setting (compared to peri-urban) reported higher anticipated, internal, and enacted stigma (β-coefficient 0.72, 0.71, 0.74). Interview participants described how stigma experiences, including HIV intersectional stigma, act individually and together as key constraints to impede care, leading to decisions not to disclose a TB diagnosis, isolation, and exclusion. Stigma resilience arose through the understanding that TB can affect anyone and should not diminish self-worth. Risks of stigma, driven by fears related to disease severity and infectiousness, led to care disengagement and impaired psychological well-being. Participants desired counselling, identifying a specific role for TB survivors as peer counselors, and community education.ConclusionsStigma is highly prevalent and negatively impacts TB care and the well-being of PWTB, warranting its assessment as a primary outcome rather than an intermediary contributor to poor outcomes. Multi-component, multi-level stigma interventions are needed, including counseling for PWTB and education for health workers and communities. Such interventions must incorporate contextual differences based on gender or setting, and use survivor-guided messaging to foster stigma resilience.Supplementary informationThe online version contains supplementary material available at 10.1186/s44263-024-00070-5.
Research prioritisation in preparedness for and response to outbreaks of high-consequence pathogens: a scoping review
Abstract Background Priority setting for research on epidemic/pandemic-prone pathogens is essential for the allocation of limited resources to optimise impact. It involves the identification of gaps in knowledge crucial to effective preparedness and response to outbreaks. This review maps priority-setting exercises, reviews their approaches to research prioritisation and describes associated monitoring and evaluation processes for research priorities on high-consequence pathogens. Methods Using search terms associated with high-consequence pathogens, as defined by the WHO (2020), EMERGE (2019), European CDC (2022) and the Association of Southeast Asian Nations (2021), and research prioritisation, we searched WHO Global Index Medicus; Ovid Medline; Ovid Embase; Ovid Global Health; and Scopus. Grey literature sources were Google Scholar and the WHO websites, complemented by recommendations from stakeholder consultation. Two independent reviewers screened abstracts and full-texts including documents describing research prioritisation activities. Results were analysed using descriptive statistics and narrative synthesis. Results We identified 125 publications presenting priority setting activities on 17 high-consequence pathogens published between 1975 and 2022. Most (62%) were related to SARS-CoV-2, 5.6% to Ebola virus and 5% to Zika virus. Three different broad approaches to setting priorities were identified, most (53%) involved external consultations with experts. Few (6%) indicated plans to monitor progress against set priorities. Conclusions Our results highlight the diversity in research prioritisation practice in the context of high-consequence pathogens and a limited application of the existing standards in health research prioritisation. An increased uptake of these standards and harmonisation of practice may improve quality and confidence and ultimately improve alignment of funded research with the resulting priorities.
Gaps in the global health research landscape for mpox: an analysis of research activities and existing evidence
Abstract Background Since December 2022, human cases of mpox in the Democratic Republic of the Congo (DRC) have risen at unprecedented rates. We identified a need for systematic mapping of the active research landscape and evidence, assessing their alignment with both local and global research priorities, to inform urgently needed research investments to support response efforts. Methods We conducted a mapping review of global research funding and international clinical trial registries and established a systematic rapid research needs appraisals platform to identify existing evidence gaps on mpox research. We analysed the alignment of these to established research categories and both local and globally identified mpox-specific research priorities. Results We identified 124 ongoing mpox research grants, 79 registered trials and 415 published studies. Most grants (85.0%, n = 105/124), clinical trials (49.3%, n = 39/79) and primary studies (57.7%, n = 205/355) were conducted in high-income countries, with most evidence published in response to the 2022 clade II global mpox outbreaks. Research funding has been focussed on vaccine and therapeutic pre-clinical development. Key gaps remain in both ongoing research and evidence relating to clinical characterisation among populations at risk, clinical trials on effective medical countermeasures specific to clade I, social sciences, health systems research, and healthcare and community protection. Conclusions Our findings highlight persistent research gaps related to mpox clade Ib, particularly the limited knowledge on its characteristics and a lack of ongoing efforts to develop effective medical countermeasures, posing a risk to control efforts. Aligning research and investments to locally and globally identified research priorities and evidence gaps will help support national, regional and international responses to prevent transmission and improve outcomes.
The role of counselling in tuberculosis diagnostic evaluation and contact tracing: scoping review and stakeholder consultation of knowledge and research gaps
Abstract Background Tuberculosis (TB) care cascade analyses show large gaps at early stages, including care-seeking and diagnostic evaluation, where promising interventions to decrease attrition are urgently needed. Person-centered care is prioritized in the World Health Organization’s End TB strategy; yet little is known about how it is delivered and can be optimized. Recommendations for counselling, a core component of person-centered care, are largely limited to its role in improving TB treatment adherence. The role of counselling to close key diagnostic gaps in the care cascade is poorly understood. Methods We conducted a scoping review to identify evidence on the use of counselling at TB diagnosis, for both people with presumptive TB and index patients to promote patient retention and contact tracing. Using search terms for TB, diagnosis and counselling, we systematically searched PubMed, EMBASE and Web of Science. Two independent reviewers screened all abstracts, full-texts, extracted data and conducted a quality assessment. We used thematic analysis to identify key themes. Results After screening 1785 articles, we extracted data from 15 studies and determined that the major themes best corresponded to the following gaps in the TB care cascade: care-seeking, pre-diagnosis, and pre-treatment. Studies were conducted across varied settings including pharmacies, primary health centres, and clinics, primarily in high TB incidence countries. No study directly evaluated the impact of counselling on outcomes such as treatment initiation or retention in care. Included studies suggested counselling may play an important role in improving the uptake of diagnostic testing and contact tracing. Barriers to counselling included time and personnel requirements. Stakeholder consultation emphasized the importance of high-quality counselling as a core tenet of TB care. Conclusion Data on the impact of counselling to improve TB case detection are absent from the literature. The shift towards person-centred care for TB presents an opportunity to incorporate counselling during earlier stages of the TB care cascade; however, evidence-based approaches are needed. Implementation research is needed to operationalize and evaluate counselling to strengthen high-quality TB care delivery.
The Utility of Systems Thinking in the Context of Infectious Disease Surveillance in India
Abstract This chapter demonstrates the utility of systems thinking in practice by providing an overview of the infectious disease surveillance system in India using general systems theory. System mapping and systems dynamics modelling, in the form of a causal loop diagram, are used to visualize the key policies, actors, and institutions involved. Focus is placed on all six of the World Health Organization’s (WHO) Health System Strengthening building blocks, with an emphasis on service delivery and information. Systems maps of tuberculosis and measles surveillance, which are covered under two separate surveillance systems, provide a deeper analysis of the different and complex reporting processes involved in disease surveillance. Case detection, reporting, analysis, and response are vital steps involved in any surveillance system. Using information gathered from India’s infectious disease surveillance portal, literature, and key informant interviews, systems thinking is applied to analyze and reflect on gaps and opportunities to pave the way for future reforms.
Analysing interventions designed to reduce tuberculosis-related stigma: A scoping review
Stigma is a critical barrier for TB care delivery; yet data on stigma reduction interventions is limited. This review maps the available literature on TB stigma reduction interventions, using the Health Stigma and Discrimination framework and an implementation analysis to identify research gaps and inform intervention design. Using search terms for TB and stigma, we systematically searched PubMed, EMBASE and Web of Science. Two independent reviewers screened all abstracts, full-texts, extracted data, conducted a quality assessment, and assessed implementation. Results were categorized by socio-ecological level, then sub-categorized by the stigma driver or manifestation targeted. After screening 1865 articles, we extracted data from nine. Three studies were implemented at the individual and interpersonal level using a combination of TB clubs and interpersonal support to target internal and anticipated stigma among persons with TB. Two studies were implemented at the interpersonal level using counselling or a video based informational tool delivered to households to reduce stigma drivers and manifestations. Three studies were implemented at the organizational level, targeting drivers of stigma among healthcare workers (HW) and enacted stigma among HWs. One study was implemented at the community level using an educational campaign for community members. Stakeholder consultation emphasized the importance of policy level interventions and education on the universality of risk to destigmatize TB. Review findings suggest that internal and anticipated TB stigma may be addressed effectively with interventions targeted towards individuals using counselling or support groups. In contrast, enacted TB stigma may be better addressed with information-based interventions implemented at the organizational or community level. Policy level interventions were absent but identified as critical by stakeholders. Implementation barriers included the lack of high-quality training and integration with mental health services. Three key gaps must be addressed in future research: consistent stigma definitions, standardized stigma measurement, and measurement of implementation outcomes.
Clinical benefit of AI-assisted lung ultrasound in a resource-limited intensive care unit
Abstract Background Interpreting point-of-care lung ultrasound (LUS) images from intensive care unit (ICU) patients can be challenging, especially in low- and middle- income countries (LMICs) where there is limited training available. Despite recent advances in the use of Artificial Intelligence (AI) to automate many ultrasound imaging analysis tasks, no AI-enabled LUS solutions have been proven to be clinically useful in ICUs, and specifically in LMICs. Therefore, we developed an AI solution that assists LUS practitioners and assessed its usefulness in a low resource ICU. Methods This was a three-phase prospective study. In the first phase, the performance of four different clinical user groups in interpreting LUS clips was assessed. In the second phase, the performance of 57 non-expert clinicians with and without the aid of a bespoke AI tool for LUS interpretation was assessed in retrospective offline clips. In the third phase, we conducted a prospective study in the ICU where 14 clinicians were asked to carry out LUS examinations in 7 patients with and without our AI tool and we interviewed the clinicians regarding the usability of the AI tool. Results The average accuracy of beginners’ LUS interpretation was 68.7% [95% CI 66.8–70.7%] compared to 72.2% [95% CI 70.0–75.6%] in intermediate, and 73.4% [95% CI 62.2–87.8%] in advanced users. Experts had an average accuracy of 95.0% [95% CI 88.2–100.0%], which was significantly better than beginners, intermediate and advanced users (p < 0.001). When supported by our AI tool for interpreting retrospectively acquired clips, the non-expert clinicians improved their performance from an average of 68.9% [95% CI 65.6–73.9%] to 82.9% [95% CI 79.1–86.7%], (p < 0.001). In prospective real-time testing, non-expert clinicians improved their baseline performance from 68.1% [95% CI 57.9–78.2%] to 93.4% [95% CI 89.0–97.8%], (p < 0.001) when using our AI tool. The time-to-interpret clips improved from a median of 12.1 s (IQR 8.5–20.6) to 5.0 s (IQR 3.5–8.8), (p < 0.001) and clinicians’ median confidence level improved from 3 out of 4 to 4 out of 4 when using our AI tool. Conclusions AI-assisted LUS can help non-expert clinicians in an LMIC ICU improve their performance in interpreting LUS features more accurately, more quickly and more confidently.
Acceptance and User Experiences of a Wearable Device for the Management of Hospitalized Patients in COVID-19–Designated Wards in Ho Chi Minh City, Vietnam: Action Learning Project
Background Wearable devices have been used extensively both inside and outside of the hospital setting. During the COVID-19 pandemic, in some contexts, there was an increased need to remotely monitor pulse and saturated oxygen for patients due to the lack of staff and bedside monitors. Objective A prototype of a remote monitoring system using wearable pulse oximeter devices was implemented at the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam, from August to December 2021. The aim of this work was to support the ongoing implementation of the remote monitoring system. Methods We used an action learning approach with rapid pragmatic methods, including informal discussions and observations as well as a feedback survey form designed based on the technology acceptance model to assess the use and acceptability of the system. Based on these results, we facilitated a meeting using user-centered design principles to explore user needs and ideas about its development in more detail. Results In total, 21 users filled in the feedback form. The mean technology acceptance model scores ranged from 3.5 (for perceived ease of use) to 4.4 (for attitude) with behavioral intention (3.8) and perceived usefulness (4.2) scoring in between. Those working as nurses scored higher on perceived usefulness, attitude, and behavioral intention than did physicians. Based on informal discussions, we realized there was a mismatch between how we (ie, the research team) and the ward teams perceived the use and wider purpose of the technology. Conclusions Designing and implementing the devices to be more nurse-centric from their introduction could have helped to increase their efficiency and use during the complex pandemic period.
Combination of inflammatory and vascular markers in the febrile phase of dengue is associated with more severe outcomes
Background:Early identification of severe dengue patients is important regarding patient management and resource allocation. We investigated the association of 10 biomarkers (VCAM-1, SDC-1, Ang-2, IL-8, IP-10, IL-1RA, sCD163, sTREM-1, ferritin, CRP) with the development of severe/moderate dengue (S/MD).Methods:We performed a nested case-control study from a multi-country study. A total of 281 S/MD and 556 uncomplicated dengue cases were included.Results:On days 1–3 from symptom onset, higher levels of any biomarker increased the risk of developing S/MD. When assessing together, SDC-1 and IL-1RA were stable, while IP-10 changed the association from positive to negative; others showed weaker associations. The best combinations associated with S/MD comprised IL-1RA, Ang-2, IL-8, ferritin, IP-10, and SDC-1 for children, and SDC-1, IL-8, ferritin, sTREM-1, IL-1RA, IP-10, and sCD163 for adults.Conclusions:Our findings assist the development of biomarker panels for clinical use and could improve triage and risk prediction in dengue patients.Funding:This study was supported by the EU's Seventh Framework Programme (FP7-281803 IDAMS), the WHO, and the Bill and Melinda Gates Foundation.
Clinical characteristics, risk factors and outcomes in patients with severe COVID-19 registered in the International Severe Acute Respiratory and Emerging Infection Consortium WHO clinical characterisation protocol: a prospective, multinational, multicentre, observational study.
Due to the large number of patients with severe coronavirus disease 2019 (COVID-19), many were treated outside the traditional walls of the intensive care unit (ICU), and in many cases, by personnel who were not trained in critical care. The clinical characteristics and the relative impact of caring for severe COVID-19 patients outside the ICU is unknown. This was a multinational, multicentre, prospective cohort study embedded in the International Severe Acute Respiratory and Emerging Infection Consortium World Health Organization COVID-19 platform. Severe COVID-19 patients were identified as those admitted to an ICU and/or those treated with one of the following treatments: invasive or noninvasive mechanical ventilation, high-flow nasal cannula, inotropes or vasopressors. A logistic generalised additive model was used to compare clinical outcomes among patients admitted or not to the ICU. A total of 40 440 patients from 43 countries and six continents were included in this analysis. Severe COVID-19 patients were frequently male (62.9%), older adults (median (interquartile range (IQR), 67 (55-78) years), and with at least one comorbidity (63.2%). The overall median (IQR) length of hospital stay was 10 (5-19) days and was longer in patients admitted to an ICU than in those who were cared for outside the ICU (12 (6-23) days versus 8 (4-15) days, p<0.0001). The 28-day fatality ratio was lower in ICU-admitted patients (30.7% (5797 out of 18 831) versus 39.0% (7532 out of 19 295), p<0.0001). Patients admitted to an ICU had a significantly lower probability of death than those who were not (adjusted OR 0.70, 95% CI 0.65-0.75; p<0.0001). Patients with severe COVID-19 admitted to an ICU had significantly lower 28-day fatality ratio than those cared for outside an ICU.
ISARIC-COVID-19 dataset: A Prospective, Standardized, Global Dataset of Patients Hospitalized with COVID-19
AbstractThe International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) COVID-19 dataset is one of the largest international databases of prospectively collected clinical data on people hospitalized with COVID-19. This dataset was compiled during the COVID-19 pandemic by a network of hospitals that collect data using the ISARIC-World Health Organization Clinical Characterization Protocol and data tools. The database includes data from more than 705,000 patients, collected in more than 60 countries and 1,500 centres worldwide. Patient data are available from acute hospital admissions with COVID-19 and outpatient follow-ups. The data include signs and symptoms, pre-existing comorbidities, vital signs, chronic and acute treatments, complications, dates of hospitalization and discharge, mortality, viral strains, vaccination status, and other data. Here, we present the dataset characteristics, explain its architecture and how to gain access, and provide tools to facilitate its use.