A Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals in 2008, the prevention of healthcare-associated infections (HAIs) has continued to be a national priority. Progress in healthcare epidemiology, infection prevention, antimicrobial stewardship, and implementation science research has led to improvements in our understanding of effective strategies for HAI prevention. Despite these advances, HAIs continue to affect ∼1 of every 31 hospitalized patients,1 leading to substantial morbidity, mortality, and excess healthcare expenditures,1 and persistent gaps remain between what is recommended and what is practiced.Since the initial publication of 2 in acute-care hospitals has further highlighted the essential role of infection prevention programs and the critical importance of prioritizing efforts that can be sustained even in the face of resource requirements from COVID-19 and future infectious diseases crises.3The widespread impact of the coronavirus disease 2019 (COVID-19) pandemic on HAI outcomesCompendium: 2022 Updates document provides acute-care hospitals with up-to-date, practical expert guidance to assist in prioritizing and implementing HAI prevention efforts. It is the product of a highly collaborative effort led by the Society for Healthcare Epidemiology of America (SHEA), the Infectious Disease Society of America (IDSA), the Association for Professionals in Infection Control and Epidemiology (APIC), the American Hospital Association (AHA), and The Joint Commission, with major contributions from representatives of organizations and societies with content expertise, including the Centers for Disease Control and Prevention (CDC), the Pediatric Infectious Disease Society (PIDS), the Society for Critical Care Medicine (SCCM), the Society for Hospital Medicine (SHM), the Surgical Infection Society (SIS), and others.The  A Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals in 2008 and 2014,10 substantial progress in HAI prevention has been achieved through the combined efforts of federal, state, and local public health entities and healthcare facilities. These efforts have been supported by the US Department of Health and Human Services (HHS) National Action Plan to Prevent Health Care-Associated Infections (HAIs),11 in coordination with the Centers for Medicare and Medicaid Services (CMS) HAI reporting requirements and reimbursement penalties tied to healthcare facilities’ HAI performance regarding central-line–associated bloodstream infections (CLABSIs), catheter-associated urinary tract infections (CAUTIs), surgical-site infections (SSIs), methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections, and Clostridioides difficile infections (CDIs). Progress in healthcare epidemiology and implementation science research has led to improvements in our understanding of effective strategies for HAI prevention. Despite these advances, the Centers for Disease Control and Prevention (CDC) estimates that each day, ∼1 in 31 patients in US healthcare facilities1 contracts at least 1 infection in association with hospital care, leading to substantial morbidity, mortality, and excess healthcare expenditures.1Since the initial and updated publications of 11Based on HAI surveillance data collected by the CDC National Healthcare Safety Network (NHSN), substantial improvements were achieved in preventing CLABSI, CAUTI, CDI, and SSI between 2015 and 2019, including national decreases of 31% for CLABSI, 26% for CAUTI, 42% for CDI, and 7% for SSI.12 The coronavirus disease 2019 (COVID-19) pandemic created unprecedented challenges, affecting the ability of healthcare facilities to consistently maintain practices essential for HAI prevention and resulting in negative impacts on HAI outcomes as hospitals responded to surges of patients with COVID-19. The pandemic strained available healthcare resources including hospital beds, staffing, and medical supplies and diverted HAI prevention resources toward COVID-19 response efforts. The effect on HAI risk is reflected in the results of several studies17 as well as the CDC’s 2020 and 2021 National and State Healthcare-Associated Infections Progress Reports,17 which demonstrated substantial increases in CLABSI rates , CAUTI rates (20% increase in ICUs), VAE rates , and MRSA bacteremia rates (31% increase) in 2021 compared to 2019. These changes highlight the importance of tools such as the Compendium, which can be used by acute-care facilities to prioritize and implement HAI prevention strategies that can lead to improvements in outcomes and that are sustainable in public health crises.That positive trend was reversed starting in 2020.Compendium has provided acute-care hospitals with current, practical, and concise expert guidance to assist in prioritizing and implementing HAI prevention strategies.Since its initial publication in 2008, the Compendium: 2022 Updates are based on previously published HAI prevention guidelines available from organizations, including the Healthcare Infection Control Practices Advisory Committee (HICPAC), the CDC, Society for Healthcare Epidemiology of America (SHEA), the Infectious Disease Society of America (IDSA), the Association for Professionals in Infection Control and Epidemiology (APIC), relevant published literature, consensus of the author panels’ members, and multiorganizational review and approval of recommendations.Consistent with the 2008 and 2014 publications, the recommendations included in the Compendium: 2022 Updates authors utilized the systematic literature review process described in the SHEA Handbook for SHEA-Sponsored Guidelines and Expert Guidance Documents.18 The Compendium is not meant to supplant previously published guidelines and systematic reviews. The Compendium: 2022 Updates includes 8 articles: 6 focused on prevention of specific types of HAIs, 1 section focused on hand hygiene improvement strategies, and a new section focused on implementation strategies relevant to HAI prevention. Except for the implementation document, each section contains a statement of concern, a brief summary of surveillance and prevention approaches, recommended infection prevention interventions, proposed performance measures, and examples of implementation strategies for consideration.The 19 the Canadian Task Force on Preventive Health Care,20 and the HICPAC Evidence and Guideline Categorization Scheme  adapted from criteria utilized by the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system,Essential practices  that should be adopted by all acute-care hospitals unless a clear and compelling rationale for an alternative approach is present.Additional approaches  that can be considered for use in locations and/or hospital patient populations when HAIs are not controlled after implementation of essential practices.Compendium recommendations are categorized as follows:The decision to categorize a recommendation as an essential practice versus an additional approach was made through consensus of the author panel with input from the Expert Panel.There was high-quality evidence, but the benefit–harm balance was not clearly tipped in one direction.The evidence was weak enough to cast doubt on whether the recommendation would consistently lead to benefit.The likelihood of benefit for a specific patient population or clinical situation was extrapolated from relatively high-quality evidence demonstrating impact on other patient populations or in other clinical situations .The impact of the specific intervention was difficult to disentangle from the impact of other simultaneously implemented interventions .There appeared to be benefit based on available evidence, but the benefit–harm balance may change with further research.In general, essential practices are supported by high to moderate-quality evidence, but some recommendations with low or moderate-quality evidence are classified as essential practices when high-quality evidence was determined to be impossible to obtain and anticipated benefits strongly outweighed potential harms based on the assessment of the author panel and Expert Panel . Recommendations classified as additional approaches may be supported by low, moderate, or high-quality evidence, with the author panel and Expert Panel assessing that the benefits of the recommended approach are likely to exceed the harms . The following criteria inform the evidence level identified for a recommendation classified as an additional approach:Hospitals can prioritize their efforts by initially focusing on implementing essential practices. If HAI surveillance or a risk assessment suggests that targets are not being met by using the essential practices, hospitals should then consider adopting some or all of the additional approaches. These can be implemented in specific locations or patient populations, or can be implemented hospital-wide, depending on outcome data, risk assessment, and/or local requirements.Compendium: 2022 Updates; the overall coordination of the Compendium: 2022 Updates was directed by leads appointed by SHEA and IDSA (D. Yokoe and L. Maragakis) and by the SHEA Guidelines staff lead (V. Deloney). The SHEA Guidelines Committee and Board of Trustees and the IDSA Standards and Practice Guidelines Committee recruited 2–3 subject-matter experts in the prevention of 6 HAIs and the prevention strategy of hand hygiene to lead 12 to 14-member author panels for each Compendium section. SHEA and IDSA appointed 2–3 individuals from each panel to author the Implementation section, a new addition in the Compendium: 2022 Updates.SHEA convened 8 author panels to develop the In addition to SHEA, IDSA, APIC, and CDC, panels included representation from The Joint Commission, The Association of periOperative Registered Nurses (AORN), Society of Infectious Diseases Pharmacists (SIDP), the Surgical Infection Society (SIS), the Pediatric Infectious Diseases Society (PIDS), and others.SHEA hired a consultant medical librarian (J. Waters), who developed a comprehensive search strategy for PubMed and Embase . Articles’ abstracts were reviewed by panel members. Each abstract was reviewed by at least 2 reviewers using the abstract management software Covidence , and selected abstracts were reviewed as full text. In July 2021, the Compendium Lead Authors group voted to update the literature findings, and the librarian reran the search to update it to August 2021. Panel members screened the articles yielded by the search via Covidence and incorporated relevant references .Compendium section met as needed via video conference to develop and discuss recommendations; to rank of the quality of evidence for these recommendations; and to classify the recommendations as essential practices, additional approaches, practices that should not be a routine part of prevention, or unresolved issues. Panel members reviewed and approved each document and its recommendations.Author Panel members for each An Advisory Group consisting of representatives from the 5 major partnering organizations  provided broad oversight over the process Table . ParticiCompendium Partners, collaborating professional organizations, and the CDC reviewed and approved the documents.The Expert Panel consisting of members with broad healthcare epidemiology and infection prevention expertise reviewed the draft manuscripts after the author panels reached consensus on the recommendations. These panel members provided input regarding recommendations and their levels of evidence. The Author Panels revised the draft recommendations to incorporate the Expert Panel’s input. Subsequently, the Expert Panel, the Compendium partners, endorsing and supporting organizations are acknowledged in Table Finally, the SHEA Guidelines Committee, the IDSA Standards and Practice Guidelines Committee, the Boards of SHEA, IDSA, and APIC, and AHA and The Joint Commission reviewed and approved the documents. In addition to the 5 Compendium Writing Panels, Expert Panel, and Advisory Group complied with SHEA policies on conflicts of interest, which require disclosure of any financial or other interest within the past 2 years that might be construed as constituting an actual, potential, or apparent conflict. SHEA requires full disclosure of all relationships, including employment, consultancies, stock ownership, honoraria, research funding, expert testimony, and membership on company advisory committees, regardless of relevancy to the topic. Disclosed relationships that are associated with potential conflicts of interest are evaluated in a review process that includes the SHEA Conflict of Interest Committee and may include the Board of Trustees and editors of Infection Control and Hospital Epidemiology. The assessment of disclosed relationships for possible conflicts of interest has been based on the relative weight of the financial relationship  and the relevance of the relationship . Compendium participants with potential conflicts were required to submit a plan detailing the process that would be used to avoid any effects of these conflicts. Decisions were made on a case-by-case basis as to whether an individual’s role should be limited because of a conflict. Potential conflicts are listed in the Acknowledgments of the individual articles and in the Executive Summary.All members of the Compendium Author Panel leads and other appropriate content experts will assess the need for updates to Compendium recommendations. Decisions regarding the timing of future Compendium updates will be made by SHEA in collaboration with IDSA, APIC, AHA, and The Joint Commission.At ∼5-year intervals, the SHEA Guidelines Committee, with the


National strategies for addressing chronic kidney disease (CKD) are crucial to improving kidney health. We sought to describe country-level variations in non-communicable disease (NCD) strategies and CKD-specific policies across different regions and income levels worldwide. The International Society of Nephrology Global Kidney Health Atlas (GKHA) was a multinational cross-sectional survey conducted between July and October 2018. Responses from key opinion leaders in each country regarding national NCD strategies, the presence and scope of CKD-specific policies, and government recognition of CKD as a health priority were described overall and according to region and income level. 160 countries participated in the GKHA survey, comprising 97.8% of the world’s population. Seventy-four (47%) countries had an established national NCD strategy, and 53 (34%) countries reported the existence of CKD-specific policies, with substantial variation across regions and income levels. Where CKD-specific policies existed, non-dialysis CKD care was variably addressed. 79 (51%) countries identified government recognition of CKD as a health priority. Low- and low-middle income countries were less likely to have strategies and policies for addressing CKD and have governments which recognise it as a health priority. The existence of CKD-specific policies, and a national NCD strategy more broadly, varied substantially across different regions around the world but was overall suboptimal, with major discrepancies between the burden of CKD in many countries and governmental recognition of CKD as a health priority. Greater recognition of CKD within national health policy is critical to improving kidney healthcare globally. Estimates indicate that almost 10% of the world’s population are affected by some form of CKD accounting for 1.2 million deaths annually [se (NCD) .The large and growing global burden of CKD has far reaching implications for individuals and health systems. Most people with CKD die prematurely due to cardiovascular disease before reaching kidney failure, with poorer outcomes observed especially for those with diabetes . CKD is These realities highlight the importance of recognizing and prioritizing CKD care through a broader NCD strategy and through CKD-specific policies. Previously however, CKD has not been given the priority it deserves as a cause, consequence and risk multiplier of many other priority NCDs. The United Nations Sustainable Development Goals (SDGs) have set a target for reducing premature mortality from priority NCDs by a third by 2030 . Whilst The International Society of Nephrology (ISN) Global Kidney Health Atlas (GKHA), now in its second iteration, sought to provide important information on CKD risk factors, the burden and consequences of CKD, and gaps in specific kidney care areas in different countries around the world . The ISNWe herein report on national NCD and CKD-specific strategies and policies for addressing CKD around the world to better understand variations across regions and country income levels.The second iteration of the GKHA was a cross-sectional survey conducted by the International Society of Nephrology (ISN). Detailed descriptions of the sampling approach, survey development, data handling, statistical analysis, and main results have been previously published , 11. BriWe performed a comprehensive review of the literature with an information specialist to synthesize national health policies and strategies for addressing CKD. Data were collected from government reports, national registries, and published as well as grey literature. This included data from the World Health Organization Global Health Observatory and the WHO Non-Communicable Disease Strategy. As part of this review, we identified the existence of national NCD strategies and whether CKD was included as part of an NCD strategic plan or addressed directly in a stand-alone policy. The existence and type of CKD-specific policies were also evaluated. We assessed specific kidney conditions  covered by national policies, where available. Finally, government recognition of CKD as a priority in policy documents and the presence of national advocacy groups were also assessed. Data from desk research were supplemented by country-specific survey data.www.redcapcloud.com).We conducted a survey as an online questionnaire. The survey was administered electronically to representatives of all 182 countries with ISN affiliate societies between July and October 2018. We identified three key opinion leaders from each country: (1) a leader or president of a nephrology society, (2) a leader of a consumer representative organization, and (3) a policymaker, thus ensuring a diverse representation of perspectives from survey responders. Invitations were sent to key opinion leaders in each country to participate in the survey , which included a link to the survey’s online portal  were involved in the development of the survey. The following organisations were involved in the survey, and their representatives were also selected to respond to the survey: European Kidney Patients’ Federation, International Federation of Kidney Foundations, Kidney Foundation of Canada, Kidney Health Australia and the US National Kidney Foundation.28 The data were analyzed using Stata 14 software (Stata Corporation).The data are presented as numbers (percentages) for categorical variables, means and standard deviations for normally distributed data, and medians with interquartile ranges, or medians with minimum and maximum values for non-normally distributed data. Survey data were analyzed and stratified based on the 4 World Bank income groups  and the 10 ISN regions . The results of the online survey were reported in accordance with the Checklist for Reporting Results of Internet E-Surveys (CHERRIES) guidelines.Out of 182 invited countries, 160 (88%) participated in the GKHA survey, comprising 97.8% of the world’s population. One hundred and fifty-four countries responded to questions about national NCD and CKD strategies. Non-respondent countries were evenly distributed across regions and income groups and mostly represented smaller countries. Full details on response rates and population coverage of the survey have been previously published.Seventy-four (47%) countries had an established national NCD strategy, with substantial variability across regions. Most countries in North America, North and East Asia, Oceania and South East Asia had a coordinated strategy for addressing NCDs , whilst only 27, 29 and 34% of countries in the Middle East, South Asia, and Africa, respectively, addressed NCDs through a national strategy . 32% andThe existence of CKD-specific policies, both at national and regional levels, varied substantially according to country income . OverallDialysis and transplantation were more frequently covered in CKD-specific national policies compared to general NCD policies . HoweverGovernments more frequently recognized CKD and kidney failure as health priorities compared to acute kidney injury . OverallIn this comprehensive multinational survey of kidney care in 160 countries, we made three main observations with regards to national health policies and strategies for addressing CKD. Firstly, less than half of countries had an established NCD strategy, and overall, only a third of countries had a CKD specific policy, with substantial variation across income levels and regions on both accounts. Secondly, where CKD-specific policies existed, non-dialysis CKD care was variably addressed despite this population encompassing the vast majority of people living with CKD. Thirdly, CKD was identified as a health priority by governments in only half of countries overall, and even less frequently in low and low-middle income countries, where the largest increases in disease burden are occurring. Taken together, these findings indicate that CKD remains substantially underprioritized globally relative to its current and projected burden on individuals and health systems.Best available data indicate that CKD has a major effect on global health, both as a direct cause of morbidity and mortality and as a risk multiplier for cardiovascular disease . A largeGiven the potential for national policies and statements to influence healthcare priorities, our findings argue for urgent attention from governments and policy makers. Indeed, developing and implementing national CKD-specific policies, or integrating CKD into existing or planned NCD strategies, may assist governments and key stakeholders to evaluate and identify gaps in care and advocate for health system improvement. Where they exist, CKD registries provide critical insights, for example temporal trends in quality of care, changes in epidemiology over time and health service utilisation. This information can serve several important purposes including informing the development of CKD policies and guidelines, benchmarking implementation strategies, and serving as a tool for advocacy to urge policy makers to tackle primary prevention of NCDs and reform towards Universal Health Coverage. Multiple registries across different health systems indicate that the use of therapies with proven benefits in CKD remains unacceptably low; in India; less than half of patients with mild-moderate CKD received renin-angiotensin system blockade and statins, with similar findings observed in high-income countries –18. TherWhilst international clinical practice guidelines, position papers and scientific statements provide overarching recommendations about best practice, country-specific policies and strategies play an important role in interpreting these recommendations in the context of local disease prevalence patterns and resource availability. For example, strategies and polices for addressing CKD of unknown aetiology are most relevant to Latin America, whereas specific strategies for diabetic kidney disease may be more relevant in parts of Oceania and South East Asia , 27. TheHowever, the development and implementation of national NCD and CKD-specific strategies and policies in isolation is unlikely to substantially improve kidney health. Supporting countries to develop CKD-specific policies must be coupled with much more widespread testing for albuminuria in high-risk individuals, such as those with type 2 diabetes (which remains poor even in high income countries),  greater This study has several important strengths. The ISN GKHA is one of the largest ever health-related country capacity reviews undertaken and all regions and World Bank income levels were well represented in the study. The combined use of desk research and survey responses from key on-the-ground stakeholders and national and regional leaders ensured the data were accurate. The survey was based on a well validated framework for assessing healthcare capacity based on the World Health Organisation health system building blocks. However, our findings should be interpreted in light of some limitations. While the survey was completed by national leaders, key consumer representative organizations and policymakers, responses may not have captured variations within large countries where policies may have varied across jurisdictions. Responses may also have been affected by respondents’ knowledge and experience and been in part subjective. More granular details on the nature of CKD-specific policies, including variations in local NCD or CKD-specific policies  within countries were not collected given the size and scope of the GKHA. The GKHA also did not collect information on the implementation of NCD or CKD specific policies, both at a national or local level, which highlights the value of studies that may be able to summarize variations in adherence to guidelines and outcomes. Such implementation studies will be critical to ensure the translation of evidence and guidelines to improve population health for CKD and related NCDs. Nevertheless, this study provides the most comprehensive global overview to date of national health policies and strategies for addressing CKD, which may serve as an advocacy tool to promote the development of national strategies and policies. Future iterations of the GKHA can also be used to gauge progress over time.In summary, the existence of CKD-specific policies, and a national NCD strategy more broadly, varied substantially across different regions around the world but was suboptimal overall. Greater recognition of CKD within national health policies and NCD strategies is critical to improving kidney healthcare globally.S1 Fig(EPS)Click here for additional data file.S2 Fig(EPS)Click here for additional data file.S3 Fig(EPS)Click here for additional data file.


Regulatory and other governance arrangements influence the introduction of medical devices into health systems and are essential for ensuring their effective and safe use. Challenges with medical device safety, quality and use are documented globally, with evidence suggesting these are linked to poor governance. Yet, medical device regulation and oversight remain inadequately defined and described, particularly in low-income and middle-income settings. Through this review, we sought to examine the literature available on regulatory and oversight processes for medical devices in African countries.Following a systematic approach, we searched academic databases including PubMed, Embase (Ovid) and MEDLINE (Ovid), supplemented by search for grey literature and relevant organisational websites, for documents describing medical device regulation and oversight in African countries. We summarised the data to present key actors, areas for regulation and oversight and challenges.A total of 39 documents reporting regulation and oversight of medical devices were included for analysis. Regulatory and oversight guidelines and processes were reported as inadequate, including limited pre-market testing, reliance on international certifications and limited processes for post-market monitoring and reporting of adverse events. Challenges for regulation and oversight reported included inadequate funding, personnel and technical expertise to perform regulatory functions. The literature highlighted gaps in guidelines for donated medical devices and in information on governance processes at the national level.The current literature provides a general overview of medical device regulatory guidelines and limited evidence on the implementation of regulatory/oversight processes at national and especially subnational levels. We recommend further research to elucidate existing governance arrangements for medical devices within African countries and propose a conceptual framework to inform future studies. The framework provides entry points for careful examination of governance and oversight in policy and practice, the exploration of governance realities across the health system and the influence of wider system dynamics. Regulatory and other governance arrangements are recognised as critical for ensuring quality, safety and appropriate management of medical devices within health systems. However, medical device governance, including regulation and oversight is less defined and not well understood in low-income and middle-income countries, particularly in African countries.The review shows empirical evidence on medical device regulation and oversight in African countries is limited, with the current literature providing general descriptions of national-level guidelines and processes, and limited information on medical device governance and oversight at the subnational level.The study highlights the need for further research to understand governance arrangements for medical devices across all levels of the health system. We propose a conceptual framework to guide the careful examination of medical device governance and oversight and explore where current policy and practice might be improved.Health technologies including medical devices have shown potential to improve the quality, safety and outcomes of healthcare delivery.2 4Governance is well recognised as a critical function and building block of the health system.7 9medical devices specifically.11 13Governance arrangements for health technologies are influenced by how the technology is defined or categorised.Concerns about the regulation and oversight of medical devices continue to be raised globally, owing to the significant number of medical devices found to be of poor quality, unsafe and abandoned across health settings.2 19–21Most of these challenges are linked to inadequate governance of medical devices, including regulation, oversight and management.Overall, medical device regulation and oversight processes within Africa are not clearly understood. This scoping review explored the nature and extent of the literature available on how medical devices are regulated and overseen, as part of governance arrangements within health systems in African countries.et al.The scoping review was conducted following the guidance provided by the Joanna Briggs Institute Manual for Evidence Synthesis,10.1136/bmjgh-2023-012308.supp3Supplementary data10.1136/bmjgh-2023-012308.supp5Supplementary dataHow are medical devices categorised and defined in the literature for regulation and oversight?What regulatory guidelines and processes are in place in African countries, and do these differ by categorisation/classification of medical devices?How are governance processes implemented at the national and subnational levels, and which are the actors involved?What are the challenges and opportunities for improving regulatory and oversight guidelines and processes?To identify keywords related to the review topic and refine the search strategy, a preliminary database search was conducted in MEDLINE and PubMed in July 2021. Following this, a definitive search to identify relevant publications was conducted between July and August 2021 in seven databases including PubMed, Embase (Ovid), Scopus, MEDLINE (Ovid), Web of Science, CINAHL (EBSCOhost). Keywords and search terms for the review included ‘medical devices’, ‘regulation’, ‘governance’, ‘oversight’, ‘sub-Saharan Africa’ and their synonyms. The search terms, including keywords and MeSH  terms for PubMed, are shown as an example in 10.1136/bmjgh-2023-012308.supp4Supplementary dataBox 1((((“Equipment and Supplies”(MeSH))) OR )) AND ((“Africa South of the Sahara”(MeSH)) OR ((“Subsaharan Africa”(Text Word) or “Sub-Saharan Africa”(Text Word) or Angola or Benin or Botswana or “Burkina Faso”(Text Word) or Burundi or “Cabo Verdi”(Text Word) or Cameroon or “Cape Verde”(Text Word) or “Central African Republic”(Text Word) or Chad or Comoros or Congo or “Cote d'Ivoire”(Text Word) or Djibouti or “Equatorial Guinea”(Text Word) or Eritrea or Eswatini or Ethiopia or Gabon or Gambia or Ghana or Guinea or Guinea-Bissau or Kenya or Lesotho or Liberia or Madagascar or Malawi or Mali or Mauritania or Mauritius or Mozambique or Namibia or Niger or Nigeria or Reunion or Rwanda or “Sao Tome”(Text Word) or Principe or Senegal or Seychelles or “Sierra Leone”(Text Word) or Somalia or “South Africa”(Text Word) or Sudan or Swaziland or Tanzania or Togo or Uganda or “Western Sahara”(Text Word) or Zambia or Zimbabwe) OR (“east africa*“(Text Word) OR “central africa*“(Text Word) OR “southern africa*“(Text Word))))) AND ((regulation(Title/Abstract) OR oversight(Title/Abstract) OR governance(Title/Abstract) OR “regulatory framework*“(Title/Abstract) OR “regulatory establishment”(Title/Abstract) OR “regulatory process*“(Title/Abstract) OR “regulatory authorit*“(Title/Abstract) OR “regulatory capacity”(Title/Abstract)) OR ) OR “Government Regulation”(MeSH)))MeSH, Medical Subject Headings.Similar keywords and terms were used to search other non-indexed databases such as Science Direct, African Journals Online, African Digital Archive and Policy Commons. Furthermore, a grey literature search was conducted using Google and Google Scholar, including a search through the WHO website, identified as a key organisation involved in medical device regulation in Africa. The reference lists of included studies were searched to identify additional material of relevance for inclusion in the review.The criteria for inclusion and exclusion of the sources of evidence are shown in To extract study characteristics and other relevant details, a data collection tool was developed. Data extracted included study characteristics such as authors, publication year, publication type and country/region of focus. Also extracted were information on, available regulatory frameworks, medical device definition, device classification, core regulatory functions/phases, actors involved, challenges with, and opportunities to improve regulation and oversight. These categories were based on themes within included studies and a previous WHO report which identified key areas for the assessment and regulation of medical devices.As the main purpose of this review was to broadly map the existing literature, a formal assessment of the methodological quality of the included studies was not undertaken. Data extracted were summarised using figures, tables and narrative summaries.As part of the scoping review methodology, consultations with three researchers identified through our networks for their experience within the field of health system governance and implementation of health technologies in African countries were held. Discussions followed the initial search and study selection process, to help refine the search strategy and identify any key missing resources. These researchers were also consulted to share the findings and provided useful insights for the synthesis of findings.The systematic search and screening of literature resulted in a total of 444 publications identified. Of these, 39 were included in the review for analysis. These include 10 journal articles,10.1136/bmjgh-2023-012308.supp1Supplementary data10.1136/bmjgh-2023-012308.supp2Supplementary dataThe most common definition was the WHO-Global Harmonization Task Force (WHO/GHTF) harmonised definition,35 39 45Box 2Medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of:Diagnosis, prevention, monitoring, treatment or alleviation of disease.Diagnosis, monitoring, treatment, alleviation of or compensation for an injury.Investigation, replacement, modification or support of the anatomy or of a physiological process.Supporting or sustaining life.Control of conception.Disinfection of medical devices.Providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.The key criteria used for the classification of medical devices was the risk of the medical device, that is, the potential of a medical device to cause harm or injury to the patient/end-user while in use.34 39 40 46From the literature, most countries in Africa used a four-group/tier classification system.Several actors were described in the literature. Nearly two-thirds (n=31) of the included studies reported an NRA.35 40 43 44The roles of these actors were not adequately described in the literature. For NRAs, the availability of a legal framework was cited as important, as this provided scope and legal backing for the NRA’s activities and empowered it to enforce its regulations.45 46Pre-market controls were concerned with the assessment of safety and functionality/performance of the medical device, and quality systems for the manufacture of the product.35 39These device attributes were usually assessed before gaining approval to market the device in a country or region, and manufacturers took primary responsibility to ensure conformity with the regulatory requirements and standards.46For most countries, pre-market regulatory assessments were reported as limited or absent.34 38Further details of the pre-market assessment of medical devices were limited. Requirements for clinical trials of medical devices were reported in a few countries including Zambia, Burkina Faso, South Africa, Tanzania39Overall, the literature suggests most medical devices enter African country markets with limited pre-market regulation and may be sold and used without further testing of performance or safety.42 43 46Among the included literature, the most common reasons reported related to inadequate pre-market assessments were: limited scientific/technical capacity to conduct the necessary assessments and the high costs of regulatory evaluations,56Two studies reported tensions existing between agencies/organisations responsible for the regulation of medical products, resulting in a lack of clarity of regulatory requirements and duplication of responsibilities.34 36 55Studies reported African countries relied on or recognised the certification or evidence of pre-market assessments conducted by the NRAs and/or third-party organisations (referred to as notified bodies) of other countries such as the USA, Canada, Japan, Australia and the European Union (EU).35 39 42 56Placing-on-market regulations were closely related to the pre-market phase, concerned with the distribution and sale of medical devices in countries and included import controls, vendor establishment or registration, the listing of products, advertising controls (including appropriate labelling) and any after-sale vendor obligations.39 40 47CE mark/certificate of free sale, often without any additional in-country regulatory processes.43As with pre-market regulation, several countries recognised or accepted certificates issued by institutions such as the US FDA, WHO prequalification and the EU The terms post-marketing surveillance (PMS), marketing surveillance and vigilance were used interchangeably in the literature to refer to post-market regulations and controls. Overall, PMS or vigilance activities referred to ongoing monitoring of the quality, safety and performance of medical devices while the product is in the market or used.39 40 42 44 46Some countries were reported to have guidelines for PMS which generally described the responsibilities of the manufacturer, vendor or authorised representative for reporting adverse events, control of advertising and labelling and taking field safety corrective actions.37 43 56Most countries were reported to have limited capacity for post-market regulation, including the inability to conduct quality tests on batches of products in the field and inadequate mechanisms for recall or withdrawal of substandard medical devices.43 47Although problems with donated devices were highlighted in the literature, there was limited information in the included studies on specific guidelines or policies for oversight of donated devices within countries in Africa. Donated devices were generally described as subject to similar controls and requirements for safety, quality and performance as other devices imported through the regular supply chain.34Few studies reported guidelines set by the WHO for donations of healthcare equipment to low-income settings, and regulatory support provided by international donors/organisations for medical devices donated through national disease programmes such as tuberculosis, HIV, and malaria.38 43 45Across the three phases of regulation and oversight, some cross-cutting challenges to regulation and oversight of medical devices were highlighted in the literature.First, several studies highlighted medical device regulation was inadequate and challenged by limited funding, inadequate personnel and limited technical expertise and capacity of national regulatory authorities for oversight.34 35 38 40 43Next, clear and specific guidance for regulatory oversight of donated and refurbished medical devices and equipment was lacking despite the influx of medical devices and equipment into African countries.37 54Another challenge was the regulatory approach for medical devices in African countries largely focused on pre-market assessment (including placing-on-market controls) at the national level and less on post-market oversight. This was raised in recognition of problems with medical devices arising while in use where oversight and vigilance were reported as inadequate.36 56Finally, the diverse and varied regulatory requirements across African countries were thought to contribute to the limited access to medical devices in the region. Multiple regulations increased the costs and complexity of the registration process for manufacturers and vendors seeking to introduce devices into African markets.38 55Harmonisation of regulatory processes and requirements was the main opportunity for improving regulation and oversight of medical devices reported in the included publications.58Within African countries, the East African Community and the South African Development Community were identified as working towards harmonisation of regulatory guidelines, but this was largely focused on medicines and less on medical devices and diagnostics.Despite the recognition of the critical role of governance of medical devices in improving the quality of healthcare delivery, this review found limited published empirical literature on governance, including regulation and oversight, of medical devices in African countries. Although some relevant sources of evidence outside published empirical literature may have been missed, the findings highlight that several countries in Africa have country specific guidelines and frameworks for the regulation and oversight of medical devices, with at least 18 countries having a national regulatory framework.34 37 43 47 48 53Along with the reliance on and recognition of certifications from higher-income settings, most of the existing regulatory guidelines and processes in African countries were modelled after guidelines from such settings (including the EU and US FDA). The findings suggest medical devices with international certifications are viewed as ‘trusted sources’ of quality, performance and safety thus not requiring further scrutiny. However, previous literature highlights regulatory processes governing medical devices in high-income countries also have shortcomings.While high-income settings may be able to implement pre-market testing and approval requirements set in those contexts, the review findings indicate much of this regulatory guidance remains poorly implemented and ineffective in lower-resource settings. This may be due to challenges highlighted in this review and previous literature, including funding constraints, inadequate personnel and a lack of technical expertise among other factors.Overall, the findings indicate the core regulatory functions for medical devices identified were inadequate, ineffective and weakly enforced in African countries, from pre-market testing and approvals to post-market surveillance of devices while in use. Such weak regulation and oversight may contribute to poor-quality and unsafe medical devices entering health systems, as reported in previous studies.15Taken together, regulatory and oversight processes identified in this review largely focus on the functions of regulatory agencies at the national government level. Furthermore, the literature only provided broad descriptions of medical device regulatory guidelines and processes, with limited information on how these may have been implemented in practice at national and subnational levels. Regulation and oversight at the national level through the function of NRAs remains a vital part of medical device governance. However, as shown in the review findings, such processes alone cannot adequately address the challenges of safety, quality and poor oversight of medical devices. These challenges are known to extend beyond regulating market introduction.9 18 39 42Hence, the review findings highlight a need to further understand how countries implement governance arrangements , and how local processes interact with national/international policies and guidelines to shape governance and oversight of medical devices. This calls for the development of comprehensive frameworks which draw attention towards oversight beyond market authorisation. Such frameworks should be developed drawing on the rich insights and experiences of the various stakeholders involved in the governance of medical devices.15 19To this end, we propose an initial conceptual framework  to feed 5Key functions of governance of medical devices such as regulation, accountability, oversight and management across the medical device lifecycle are enacted through the interplay of formal and informal rules and processes; and hardware and software elements. Influencing the nature of this interplay are wider system dynamics including power relations between actors, their authority and decision-making space and professional and organisational cultures. Given this complexity, the importance is underscored, of examining governance as intended on paper and governance as implemented in practice across all levels of health systems and seeking to understand the reasons for and implications of differences. Illustrations of research questions which have been overlooked which the framework points to include:Who are the actors involved in medical device governance processes  at subnational and facility levels on paper and in practice and how might they interact?What factors  influence the everyday realities of how governance and oversight rules and processes are implemented?What are the implications of gaps between formal rules on paper and governance in practice for the regulation of medical devices across the health system?We suggest this initial framework is a potentially valuable tool to inform future research on medical device governance and oversight, in particular encouraging greater emphasis of governance realities at national and subnational levels. This work, and development of more detailed versions of elements of the framework, should encourage further studies on relatively neglected areas of research. This will allow exploration of similarities and differences across contexts and support identification of potential shared (as well as context specific) points of intervention to strengthen governance. In these ways, we hope the framework will ultimately contribute to transferable lessons on how governance rules and processes might be improved to ensure the benefits of medical devices are achieved and harms are minimised.This review employed a comprehensive, systematic search strategy identifying and mapping relevant peer-reviewed and grey literature on medical device regulation and oversight. It thus builds and expands on the knowledge from previous literature on medical device governance. However, there are some limitations. The search strategy aimed at being broad and inclusive but given the broad nature of the concepts of ‘governance’ and ‘medical device’, it is possible some relevant sources of evidence on topics related to these terms may have been excluded. Although no language limitations were specified to mitigate excluding relevant literature from non-English speaking parts of Africa, we recognise potentially relevant literature from such regions may have been missed.This study provided a broad overview of the governance, including regulation and oversight of medical devices within the African context and highlights gaps in the literature and challenges of medical device governance within this context. Current frameworks and guidelines are focused mainly on national-level guidelines and processes, which are generally described as inadequate. There is also limited information on the implementation of these national frameworks or what rules and processes apply beyond this level. Given the limited availability of empirical research on medical device governance, there is a need for future studies to examine governance arrangements carefully and elucidate where current guidance might be improved. We propose a conceptual framework in this paper to guide future more in-depth research in this regard.


To map the international literature on Permanent Health Education initiatives to care for people with obesity. In total, six databases were searched without any language or publication period restriction according to the Joana Briggs Institute manual for evidence synthesis and the Prisma extension for scoping reviews (Prisma-ScR). Articles were independently analyzed by four reviewers and data, by two authors, which were then analyzed and discussed with our research team. After screening 8,780 titles/abstracts and 26 full texts, 10studies met our eligibility criteria. We extracted data on methodologies, themes, definitions of obesity, outcomes, and gaps. Most initiatives came from North American countries without free or universal health systems and lasted a short period of time (70%), had multidisciplinary teams (70%), and addressed sub-themes on obesity approaches (90%). Results included changes in participants’ understanding, attitude, and procedures (80%) and gaps which pointed to the sustainability of these changes (80%). This review shows the scarce research in the area and a general design of poorly effective initiatives, with traditional teaching methodologies based on information transmission techniques, the understanding of obesity as a disease and a public health problem, punctual actions, disciplinary fragmentation alien to the daily work centrality, and failure to recognize problems and territory as knowledge triggers and to focus on health care networks, line of care, the integrality of care, and food and body cultures. In a recent report, the Lancet Commission on obesity offers the concept of a global syndemic, tracing an association between three pandemics: obesity, malnutrition, and climate change, phenomena with common systemic factors and complex relations interacting with each other to contribute to anew narrative needed to accelerate the social movement of change. Guidelines to organize obesity care lines point to Permanent Health Education (PHE) actions, programs, and primary care policies as a powerful political-pedagogical strategy to change health care providers’ understanding, formulation, and thinking, turning territorial realities into beacons for critical, systemic, and transformative actions.A global panorama of this magnitude invites policymakers, researchers, managers, and healthcare providers to think about new forms of care which are articulated in a network, structured in longitudinal lines, and based on the integrality of care and body and food culturesThus, this review aims to systematically map and summarize the evidence found in this area via the following research question (RQ): what has the international literature produced about permanent education initiatives so health care providers can care for people with obesity? It also explores the following sub-issues:(RQ1) What themes and methodologies do these initiatives use?; (RQ2) How do these studies conceptualize obesity?; (RQ3) What are the results of these initiatives?; and (RQ4) What gaps do these studies show? and the Joana Briggs Institute (JBI) recommendations, which were reviewed by our research team. Its final draft was registered on Open Science Framework on February 24, 2021(https://osf.io/g5jkh/).The protocol of this review was elaborated according to Prisma-PStudies  dealing with permanent education initiatives for the primary care of people with obesity (overweight and obese) were assessed by this review. Language or year of publication restrictions were ignored to expand the number of retrieved studies. Quantitative, qualitative, and mixed studies were included to map different methodological approaches.Invitro studies with animals, texts, opinion papers, letters, conference summaries, and editorials were excluded because they failed to meet the objectives of this review.Studies which met the following criteria were excluded: participants who were not primarily healthcare providers; initiatives ignoring PHE, i.e., if they had no intention of educating professionals to work in health care networks; those outside primary care; and educational initiatives which dealt with issues other than obesity.At first, a limited search was conducted on two databases, Medline (PubMed) and CINAHL, followed by an analysis of the words contained in the title and abstract of the retrieved articles and of the terms in the indices and keywords used to describe the articles. To find as much relevant evidence as possible, our search for studies was comprehensive and systematic. Medline via PubMed, Embase, CINAHL, Scopus, Web of Science, and Lilacs were the databases selected for research. Nevertheless, Google Scholar and Open Gray were also searched for grey literature. Our search strategy was developed with descriptors which were synonymous to those in MeSH (PubMed), DeCS (Lilacs), and Emtree (Embase). Our search strategy was applied to these data bases by a reviewer and results, exported to Rayyan for duplicate removal and initial sorting. Reference lists with the included studies were evaluated. A wide consultation with specialists in the area was carried out to recover important studies which our searches failed to retrieve. Subsequently, the selected publications were exported to EndNote web. Our research team was assisted in this process by a librarian specialized in health (GFXJ). The search strategies developed for each database are included in an additional file .Selections based on titles/abstracts and full texts were made in Rayyan by four independent reviewers  and disagreements were resolved in pairs or by a third reviewer’s intervention. In the absence of additional information or data, the authors of the chosen studies were contacted.The entire selection was accompanied by two pilot tests. On the first stage, 25 titles/abstracts from sources of evidence were read and, on the second, five others, in full. Random sample were included in both sources. These studies were screened by our entire team according to our eligibility criteria, showing an agreement above 75%, as per the JBI Manual for Evidence Synthesis.Data were summarized by the following characteristics: articles ; participants (demographic and sample size); educational initiatives ; and research . The JBI Sumari software was used to map our findings.The entire data extraction process was carried out by two independent reviewers (CGM and VMS), who discussed results and procedurally and simultaneously updated our data graph. To increase consistency among reviewers, a pilot source extraction test was performed with a random sample of four publications, about which reviewers showed an agreement above 75% on the mapped data. Any divergence was resolved by consensus or by the intervention of a third reviewer. recommendations, both in line and describing how results related to the questions and objectives of this review.Results were synthesized by frequency and thematic analysis. Textual data were thematically analyzed by a reviewer and verified by a second one (CGM and MLPS) via ATLAS.ti. A tabular diagram, word cloud (Wordcloud.com), data graph, and narrative summary were elaborated by the authors according to Prisma ScR by a survey in our reference lists. We removed 1390 duplicates and evaluated 8,780 titles and abstracts and 26 full-text articles for eligibility. We neither found documents in the grey literature nor by consulting specialists. Subsequently, 10 studies, reported in 15 publications, met our eligibility criteria.We retrieved 10,169 publications, one of which, Canada (20%), Israel (10%), and Iran (10%) (Appendix S2). In total, eight publications were linked to three mixed studies, seven were quantitative studies, of which one was a dissertation. Most were original studies (100%) conducted in countries without universal health systems (60%) which received public funding (30%), appeared in journals whose central scope addressed training healthcare providers (30%), had quasi-experimental methods (60%)aimed at primary care (80%), and contained multidisciplinary groups (70%).All studies were published after 2004 and originated in the United States of America (60%), including biomedical, psychological/behavioral, ecological, cultural, and environmental ones; and professional qualification strategies (40%). We must point out that twostudies qualitatively assessed the involved healthcare providers’ current educational needs to build content panels for these initiatives, a participation strategy evinced in the PHE methodological principle.Most initiatives focused on self-reported approaches to obesity (80%) and/or discussion (60%) as teaching strategies; which lasted one day (70%)and included individual (80%) in-person participation (80%) in a single meeting (50%). Some initiatives used data from participants’ reality, such as the prevalence of local obesity and evaluations of medical records of patients with obesity.Most studies showed the following methodological profile for their initiatives: oral exposure (60%) linked to world public health (30%) and complex systems (10%) which is common in primary care (10%). The other studies brought concepts such as world epidemic (20%); prevalent chronic conditions (10%); and risk factors for non-communicable chronic diseases (20%). Studies focused on explanatory models of obesity: (i) body mass indices (BMI) (40%); (ii) the environment (20%); (iii) culture (20%); (iv) ecology (10%); and (v) the perspective of a complex system, in which individual behaviors related to nutrition and physical activity interact with genetics, socioeconomic factors, among other factors (10%).Most studies considered obesity as a problem (60%), evaluating them via pre-research (100%), immediate post-intervention (80%), and afterone, three, six, and 12 months.All initiatives showed results on participants’ conceptual, procedural, and attitudinal changes (100%) and teaching strategies (40%).Most initiatives showed gaps related to sustaining the conceptual, attitudinal, and procedural changes promoted by their courses (50%). The included studies showed initiatives to educate healthcare providers with methodological profiles focused on specific actions, technical and instrumental biases, and subthemes which addressed obesity . Our sample addressed obesity as a public health problem, evincing a more quantitative bias between disease and risk factor. Initiative results showed changes in professionals’ concept and attitude toward obesity but only slightly altered the procedural field of caring for these patients, showing, in their gaps, the concern that future longitudinal research can investigate changes in long-term care practices.Regarding their general scope, results (n = 10) show a scarcity of research in the area and, consequently, novelty and importance for policymakers. Thus, it is necessary to consider the importance of encouraging the scientific dissemination of experiences in the everyday life of health services as evidence which can structure major scientific leaps in the area.Although widely used in its health services, we retrieved no study conducted in Latin America, in which PHE emerged in the 1980s as a methodological strategy at the initiative of the Pan American and World Health Organizations, structured in 2004 as a public policy for health training linked to national health services and disseminated throughout the Brazilian territory endorses its pioneering and advancing spirit in scientific research on obesity handling and management. It historically adopted a mixed health system model, lacking universal health coverage and whose private sector lies higher than the public one. Moreover, it has institutionalized the issue of obesity – a process which corroborated, according to Poullain, to place it as a world public health issue.The fact that most studies come from the USA which outline the scope of such investigations, both assuming the hegemony of biomedical biases and the “warlike” logic of dealing with obesity, which, according to Foucault, controls body mass structure biopower techniques centered on the individualized body and considers it relevant to understand the tensions, logics, and interests around obesity to think of care strategies more focused on integrality, respect for individuality, and a critical position against the stigma it carries.Such conditions signal a shift from the epistemological status of obesity to a more quantitative definition which suffers great interference from economic interests . PHE, on the other hand, proposes changing the conception and practices of health training and incorporating teaching and learning into the daily life of services, with practice as a source of knowledge and problems that increase teams’ critical thinking based on network, comprehensive care, and multiprofessional, interdisciplinary, and intersectoral approaches.In our analysis of the context of these actions, the included studies show initiatives which mainly relate to CE — punctual actions, disciplinary fragmentation,andtraditional teaching methodologies based on transmission techniques, even if some had moved toward PHE. This methodological design exposes a still present weakness in health education between what is desired and what is effectively done. It aims, for example, to offer something new using the same and exhausted strategies of knowledge mediation.This review assumed a conceptual-methodological difference between continuing education (CE) and PHE. The first, the traditional resource in health, centers around updating knowledge, usually with a disciplinary focus based on transmission techniques, thus constituting a discontinuous training strategy with time breaks. Thus, four studies claimed, as their methodological strategies, to survey both participants’ problems as guidelines to build themes/contents for their PHEinitiatives and data on the health service reality and on advocacy resources in the care forobesity, a strategy based on what Ceccim calls a four-way approach to training: teaching - care- management - social control, in which “each face involves a pedagogical call, an image of the future, an apolitical struggle, and a web of connections” (p.47). These strategies project participants’ critical approach to their realities, promoting the recognition of possibilities for emancipatory action in the face of the actual situations experienced in health services.PHE presupposes the development of educational practices focusing on the resolution of concrete problems via team discussions based on the perspective of transforming work processes, most only discussed its biomedical perspective; professional qualification strategies; relations with PHE, including the strategic development of intervention plans; and obesity handling and management. In general, initiatives mainly discussed continuous self-improvement in the search for professional and personal competence and only slightly consider the situations problematizing work to transform reality. The addressed sub-themes need to dialogue more with participants’ yearnings for change since they show a greater number of possible points of analysis when facing the same situation —obesity —, subsidizing the critical analysis of their realities to promote more critical, creative, and autonomous decision-making.The contents of the initiatives dealt with approaches toobesity which favor individual participations and teaching strategies mainly based on oral exposure; methodological conditions which, allied to institutional, political, ideological, and cultural ones, anticipate and determine the space within which training can operate its limits and possibilities: a simplified and instrumental vision of education; its low discrimination of problems to be overcome; and immediacy in projects with predetermined beginnings and ends; results pointing to methodological designs far removed from what the National PHE Policy proposes in Brazil.Educational actions in health human resources traditionally have methodological designs consisting of short actions in global public health which has a complex system and is common in primary care. Recognition as a public health issue, according to Poulain, occurs after two conditions are met: theme institutionalization and the change in the epistemological status of obesity to a more quantitative definition — either as a risk factor or a disease, consolidated by the use of BMI as an evaluation method — in a process which medicalized obesity, although limited, according to Gard & Wright.Studies conceptualized obesity as a problem used the term global “epidemic” (a concept which two studies mention), obesity has gained prominence in the media and political debate, forming a true “warlike” scenario with considerable symbolic consequences and involving different agents which are motivated by different interests, offering questionable services, products, and information in the fight against the “enemy”. Although this narrative represents the current hegemonic discourse, according to the Lancetreport and authors from the Social and Human Sciences, it offers a limited understanding in the face of the phenomenon of obesity because it ignores its complexity, a condition only one study signaled and valued by the systemic approach of PHE.Since the WHO, in their conceptual and attitudinal content, with lower expression in the procedural one, a great objective regarding primary care work collectives. Moreover, some results describe the limits and potentialities of teaching strategies, in which we find the success of those involving discussion and group work when we compared them to transmission strategies. Thus, longitudinal studies may be a good strategy to promote more lasting changes also in the field of procedural contents installed in health services.Regarding the results of these initiatives, all studies point to changes in participants. However, the most expressive are, according to the typology in Zabala highlighted that the use of strategies to understand cultural contexts (by race) within services provided significant conceptual and procedural changes for some participants, endorsing a premise of reorganizing their work process via the concept of territorialization as an instrument to diagnose and analyze health situations in local planning. Finally, regarding the products of these actions, two studies elaborated an individual intervention plan, a strategy qualifying social actors for strategic thinking/reasoning and the ability to contextualize projects for relevant healthcare problems. The latter results are the most significant and desired for health services for their transformative power and association with the real needs of the monitored population.Also regarding results, two studies recorded the importance of further research designing longer and more targeted initiatives to assess the sustainability of conceptual, attitudinal, and procedural changes, considering that, even if these initiatives achieve individual learning, they fail to always translate themselves into organizational learning, i.e., the reorganization of collective work processes, a premise of the Brazilian National PHE Policy. Some studies indicate the possibility of surveying more powerful and cost-effective teaching strategies given the exhaustion of so many traditional and discontinued strategies aimed at transmission. In this sense, the PHE launches itself as a potential political-pedagogical practice that,Regarding gaps, six studies (p.161).(…) at the same time as it disputes for the daily updating of practices according to the most recent theoretical, methodological, scientific, and technological contributions available, it is part of a necessary construction of relationships and processes which stem from within teams in a joint action – including their agents, organizational practices – involving the institution and/or the health sector and interinstitutional and/or intersectoral practices – linked to the policies in which the health acts are includedInterpreting international production shows that obesity is a public health problem, and that health education rarely questions food versus body. Bio pedagogical studies on the stigma of obesity, the “invention” of the obesity epidemic, or those with a cultural and anthropological basis are absent in the training of healthcare providers toward a clinical/assisting approach to obesity. Most studies stem from countries without a universal health system, evincing that obesity has meanings in these countries unlike those of a “Brazilian-style” PHE. Thus, the great need to encourage the dissemination of research in the area and of considering the use of PHE as urgent.and Prisma-ScR. Note also its novelty in view of the scarcity of publications in the national and international literature which focused on PHE focused on obesity care. Worldwide, the use of these syntheses is considered a priority to formulate well-informed and effective policies.The strengths of this review include its comprehensive bibliographical research in various electronic databases via a rigorous methodology suggested by JBIThis study shows limitations regarding the scarcity of evidence, especially for Latin America and mainly for Brazil, regions which have consolidated PHE. Moreover, this scope review was a huge undertaking and our results include research only up to October 2020.This scope review showed a scarcity of research in its area of interest and that most PHE initiatives for obesity care show a traditional teaching methodology centered on transmission of information techniques, punctual actions, and disciplinary fragmentation, unlike what PHE proposes. It also suggests that the concept of obesity is still mostly linked to a biomedical bias, although the literature has gradually included other causal approaches, and that short-term research fails to promote changes in the field of procedural content, making learning and organizational changes unfeasible. Future research should study continuous initiatives focused on professionals’ daily work, recognizing their problems as real and strategic knowledge triggers, considering the notion of network, line of care, integrality of care, and food and body cultures.


In 2019, the U.S. Food and Drug Administration (FDA) approved emtricitabine and tenofovir alafenamide (Descovy) as another option for HIV pre-exposure prophylaxis (PrEP) prevention for high-risk adults and adolescents. With the introduction of this new PrEP, millions of current users on emtricitabine and tenofovir disoproxil fumarate (Truvada), another PrEP medication currently used to prevent HIV transmission, have options of whether to continue their current treatment regime or transition to new treatment options. The objective of this study was to conduct a descriptive analysis to characterize user-generated social media conversations on Reddit associated with FDA-approved PrEP prevention treatment options. Key themes identified were associated with perceptions, knowledge, and attitudes associated with the transition of use of different PrEP medications. Data were collected retrospectively and prospectively from the Reddit platform for posts with keywords filtered for HIV, PrEP, and FDA-approved PrEP prevention treatment from October 2020 to December 2020. We chose the Reddit platform based on prior studies that have identified PrEP user conversations and insights on access challenges for specific AIDS communities, such as gays and men who have sex with men (MSM). Reddit posts were then manually annotated using an inductive content coding approach for key themes regarding the transition of use and other emergent themes from user-generated content. Formal coding of text data was conducted with refined codes, and sub-codes created. A total of 3,120 posts were analyzed from Reddit resulting in 315 posts that were coded for PrEP and 105 posts (33.33%) specific to user discussions regarding the transition of PrEP prevention. Overall, users expressed interest in drug switching to Descovy, particularly in the context of poorer adherence or concerns about existing side effects associated with Truvada. Other major themes included discussions about the cost of Descovy, apprehension about side effects in comparison to Truvada, insurance coverage changes, and discussions about the donation of Truvada to other users after transitioning. Among these discussions, topics related to sexual minorities, including MSM, reported concerns when considering a switch in their HIV prevention regime. Understanding the changing public perception associated with the introduction of new HIV prevention is important in the context of market access, patient safety, pharmacovigilance, and health equity, particularly among high-risk populations such as MSM. Results support the use of social media from a digital pharmacovigilance perspective to better understand emerging HIV prevention, treatment, and adherence challenges experienced by patients. In 2020, ~37.7 million people were living with human immunodeficiency virus (HIV) globally, and as of 2021, over 28.2 million people were accessing anti-retroviral therapy (ART), representing an increase of more than 20 million people accessing treatment since 2010 . ImportaIn 2012, emtricitabine and tenofovir disoproxil fumarate (brand name Truvada) was approved by the U.S. Food and Drug Administration (FDA) for use in HIV-negative individuals to reduce the likelihood of contracting HIV, in addition to its use to treat active infections , 8. SincAlthough the chemical composition of these therapies is different, studies have found both formulations to be non-inferior to each other . DescovyDespite active conversation about the similarities, differences, and possible benefits vs. risks of these different FDA-approved PrEP therapy regimes among the HIV/AIDS community, few studies have specifically examined perceptions, attitudes, and behaviors associated with the transition of use for PrEP, though several studies have been published assessing barriers and facilitators to PrEP therapy as discussed on social media –23. FurtWe used the programming language Python™ to develop a custom programming script to collect publicly available posts from Reddit. Posts were collected from Reddit over a 60-day study period (13 October 2020–11 December 2020) and allowed us to collect both retrospective data from posts that occurred prior to the date of collection and prospective data, posts collected starting on the date of collection. This data collection method and time period were chosen as it was deemed sufficient to collect both past and recent conversations regarding PrEP. Specifically, data were collected by retrieving posts from search results and sub-Reddits filtered for common PrEP and HIV-associated keywords including “HIV,” “PrEP,” “Truvada,” and “Descovy.” These keywords led to additional associated keywords and hashtags identified in Reddit conversations relating to HIV prevention and PrEP that were used for additional data collection. We chose the Reddit platform based on prior studies that have identified PrEP user conversations and insights on access challenges for specific AIDS communities, such as gay and MSM.To identify, characterize, and elucidate conversation associated with the two approved PrEP medications, Truvada and Descovy, we manually annotated all collected posts. First, we identified all signal posts. Posts were deemed as “signal” if they were (a) user-generated ; and (b) conversation discussing topics relevant to Truvada and Descovy accessibility, use and or transition of use, effectiveness, insurance coverage, and associated barriers. Advertisements of the drug, public announcements, and posts not related to Truvada and Descovy were specifically excluded from analysis as the focus of this study was to identify and characterize user-generated posts regarding behavior associated with PrEP, and with a specific focus on drug transitions, not drug promotion or HIV health education and promotion. To classify the content of Reddit posts, a general inductive approach was utilized to code the textual data for descriptive analysis . All iden = 81), specifically gay and MSM. A summary of parent and sub-code book results and corresponding de-identified examples are reported in We collected a total of 2,349 unique Reddit posts over the study period. Descriptive analysis and manual annotation of all collected posts identified 85 (4.47% or the entire dataset) signal posts. Posts that did not meet our inclusion criteria for this study but were nevertheless relevant to PrEP facilitators and barriers included posts discussing differences between post-exposure prophylaxis (PEP) and PrEP therapy, confusion regarding PrEP therapy, experiences regarding healthcare providers' lack of PrEP knowledge and training, and comments believing that Descovy advertisements only targeted certain minority populations were excluded. Based on the publicly available text in Reddit posts, the largest representation from a minority group were for members associated with the sexual minority community  pre-transition: posts regarding users who currently take Truvada, users recognizing a new PrEP medication has been approved, and users sharing or seeking knowledge regarding the differences between Truvada and Descovy and (ii) post-transition: sharing the experience of switching from Truvada to Descovy, or asking questions associated with the transition experience. In the context of PrEP drug transition, all discussions detected concerned a pathway of transition or switching from Truvada (pre-transition) to Descovy (post-transition).n = 24, 22.86%); followed by topic (A-1) associated with users sharing or seeking knowledge on potential side effects from Descovy and also discussing reasons why this influenced their decision of not to engage in drug transition ; topic (A-4) included posts in which users expressed interest in switching to Descovy because of the purported side effects experienced from Truvada ; and topic (A-2) focused on sharing or seeking insurance coverage information associated with drug switching to a new PrEP treatment and how this impacted their decision to transition or not to transition to another PrEP treatment .Among all signal posts, 62 posts  were classified in the pre-transition parent topic , we also observed four main themes. A major theme (B-3) that emerged was the discussion of side effect management after switching to Descovy . Another topic (B-2) included discussions regarding mixing Truvada and Descovy medications  remaining Truvada medication after switching to and initiating Descovy) . Topic (B-4) contained posts regarding users seeking information on how they can donate their remaining Truvada to other people who might benefit from prevention treatment access . A final sub-topic (B-1) included general discussion of the experience of switching medications and why users switched to Descovy.Among posts classified in post-transition parent topics  and concerns that arose after switching from Truvada to Descovy (post-transition).Our results add to insights generated by prior studies that have examined social media for clues regarding barriers and facilitators associated with PrEP, including specifically among gay and MSM populations. For example, a 2018 systematic review examined both peer-review studies and online posts to identify barriers and facilitators to PrEP among MSM, detecting six overarching categories that included online sources acting as facilitators to PrEP uptake and concerns about perceived side effects . A recenAdding to these prior studies that examined social media for HIV and PrEP topics, this study was able to identify specific lived experiences regarding transitions of use for PrEP therapy, a topic subject to possible social stigma as it relates to HIV status, sexual orientation, and HIV-related risk behavior. However, due to Reddit's relative anonymity as an online platform and the ability to up and downvote content, it appears to be a platform where users may be more willing to discuss stigmatizing topics . SpecifiFurthermore, discussion of the impact of perceived side effects of different PrEP medications was prominent in the drug transition of use decisions, along with the discussion of access  and cost. An additional consideration not specifically detected in this study but likely influencing the transition of use among users was the financial incentives associated with switching PrEP therapy. Descovy's regulatory approval for PrEP therapy occurred in 2019, just over 1 year prior to the generic availability of Truvada. At its introduction to the market, Descovy was offered with large commercial discounts which resulted in it launching at a 12% lower average net price than Truvada . These fImportantly, these findings provide insights that are important to post-market surveillance and pharmacovigilance efforts attempting to better understand perceptions of uptake, risk, and safety for PrEP among a community of predominantly gay and MSM users at higher risk for HIV. However, this study may not provide an extensive list of barriers and facilitators to accessing and adhering to PrEP therapy, as many people who contemplate HIV prevention or treatment may not openly discuss the unique complications they experience due to the stigmatization associated with this topic whether online or offline. Results can help inform how patients and specific gay and MSM populations in English-speaking countries experience and react to perceived adverse events and side effects and how it may impact the HIV care continuum of initiating, adhering to, and potentially transitioning between PrEP in preventing transmission . ImportaHence, future studies should adopt methodologies used in this study for non-English language social media posts to better understand the unique barriers and facilitators in regions representing the largest HIV burden and greatest PrEP use, while also examining topics not explored in this study, such as the targeting of PrEP product advertising or outreach toward specific SGM populations. Future studies should also further validate results generated from social media with other sources of patient experiences  and integrate these novel data sources into a more proactive system of interdisciplinary pharmacovigilance to ensure better uptake and adherence to PrEP. In particular, the use of digital mixed methods that combine social listening approaches with in-depth qualitative data  and robust quantitative data  designed specifically for at-risk SGM populations can better triangulate insights into PrEP barriers that can inform the development of future interventions and patient outreach.This study is primarily exploratory and descriptive in nature and has certain limitations. First, we only collected data from Reddit and limited our analysis to keywords and terms in the English language. Hence, the findings are not generalizable to all social media users who discuss transitioning between PrEP therapy, including those in other countries with higher HIV burdens but who are underrepresented in the population of Reddit users. Additionally, this study may represent an underestimate of people's experience with PrEP therapy and may not provide an extensive list of barriers to treatment due to the social stigma associated with HIV and discussing HIV-related care, including via online communities. Our collected and analyzed data sample size was also relatively small, which could lead to sampling bias. Hence, future studies should expand data collection and analysis approaches to different phrases and keywords associated with an individual's HIV-related risk behavior to obtain a more representative corpus of social media conversations and increase the sample size of data that can be analyzed. In addition, Reddit is a social media platform. There is a potential bias in using social media data including population biases, behavioral biases, content biases, and linking biases. Future studies should consider triangulating results from social listening approaches used in this study with other data sources . Future studies should also expand data collection to additional platforms, languages, and specific keywords associated with HIV exposure and risk behavior to generate a more representative corpus of PrEP-related social media conversations.The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.All information collected during this study was available in the public domain, did not include any deleted posts, and the study did not involve any interaction with users. Any user indefinable information was removed from study results and any racial and/or ethnic identifiers were presented as aggregated results to ensure anonymity. This study has been approved by WCG Institutional Review Board's (WCGIRB's). WCG IRB is registered with the Office for Human Research Protections (OHRP) and FDA as IRB00000533.HG, QX, TJM, JL, and TKM jointly conceived the study, drafted the study, conducted data collection and analysis, and wrote and agreed to the final version of this manuscript.