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BACKGROUND: Community engagement (CE) is pertinent to ethically and scientifically rigorous infectious disease clinical trials in sub-Saharan Africa (SSA). However, there are critiques that CE is not properly embedded in research processes and that there is uncertainty about what CE entails. The aim of this study was to gain an understanding of CE in infectious disease clinical trials in SSA, specifically factors affecting CE and existing strategies for engaging with communities. METHODS: Semi-structured telephone interviews were conducted with 20 community and clinical trial (CT) stakeholders who worked in SSA. The audio-recorded interviews were transcribed verbatim and analysed inductively using thematic analysis. RESULTS: Themes are as follows: 1) Communities are abandoned research-entities-a disconnect between scientific teams and communities was observed and knowledge translation was not prioritised at the community-level. 2) Us and them: community engagement teams vs investigators-CE teams expressed that researchers did not account for CE processes and often did not involve CE staff in their planning, and felt that their roles were not valued. 3) Ethical considerations: concerns and gaps-there were concerns that procedures were not standardised and that ethics processes were not adhered to. 4) Opportunities for improved CE practices-training needs were expressed, including for standardised practices, ethics, and for developing a holistic understanding of collaborating with communities. CONCLUSION: CE role players require intensive training to ensure ethical CE and that communities are treated with dignity. This includes 1) using collaborative strategies involving research and CE staff, 2) protocol-adherence that recognises CE as pertinent, 3) viewing communities as complex and building relationships that are sustainable, and 4) ensuring that knowledge translation is considered at a community-level. Further research is necessary to investigate potential training programmes that integrate these elements.
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Ensaios Clínicos como Assunto , Participação da Comunidade , Humanos , África Subsaariana/epidemiologia , Participação da Comunidade/métodos , Doenças Transmissíveis/terapia , Doenças Transmissíveis/epidemiologia , Feminino , Masculino , Adulto , Pesquisadores/psicologiaRESUMO
BACKGROUND: Poverty-related diseases (PRD) remain amongst the leading causes of death in children under-5 years in sub-Saharan Africa (SSA). Clinical practice guidelines (CPGs) based on the best available evidence are key to strengthening health systems and helping to enhance equitable health access for children under five. However, the CPG development process is complex and resource-intensive, with substantial scope for improving the process in SSA, which is the goal of the Global Evidence, Local Adaptation (GELA) project. The impact of research on PRD will be maximized through enhancing researchers and decision makers' capacity to use global research to develop locally relevant CPGs in the field of newborn and child health. The project will be implemented in three SSA countries, Malawi, South Africa and Nigeria, over a 3-year period. This research protocol is for the monitoring and evaluation work package of the project. The aim of this work package is to monitor the various GELA project activities and evaluate the influence these may have on evidence-informed decision-making and guideline adaptation capacities and processes. The specific project activities we will monitor include (1) our ongoing engagement with local stakeholders, (2) their capacity needs and development, (3) their understanding and use of evidence from reviews of qualitative research and, (4) their overall views and experiences of the project. METHODS: We will use a longitudinal, mixed-methods study design, informed by an overarching project Theory of Change. A series of interconnected qualitative and quantitative data collections methods will be used, including knowledge translation tracking sheets and case studies, capacity assessment online surveys, user testing and in-depth interviews, and non-participant observations of project activities. Participants will comprise of project staff, members of the CPG panels and steering committees in Malawi, South Africa and Nigeria, as well as other local stakeholders in these three African countries. DISCUSSION: Ongoing monitoring and evaluation will help ensure the relationship between researchers and stakeholders is supported from the project start. This can facilitate achievement of common goals and enable researchers in South Africa, Malawi and Nigeria to make adjustments to project activities to maximize stakeholder engagement and research utilization. Ethical approval has been provided by South African Medical Research Council Human Research Ethics Committee (EC015-7/2022); The College of Medicine Research and Ethics Committee, Malawi (P.07/22/3687); National Health Research Ethics Committee of Nigeria (01/01/2007).
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Saúde da Criança , Guias de Prática Clínica como Assunto , Humanos , Recém-Nascido , Lactente , Malaui , Pré-Escolar , África do Sul , Nigéria , Medicina Baseada em Evidências , Pobreza , Tomada de Decisões , Fortalecimento Institucional , Participação dos Interessados , Saúde do Lactente , Prática Clínica Baseada em Evidências , Projetos de Pesquisa , Avaliação de Programas e Projetos de Saúde , Serviços de Saúde da Criança/normas , Serviços de Saúde da Criança/organização & administraçãoRESUMO
BACKGROUND: The informed consent process is an important step in conducting ethical clinical trials, as it ensures that research participants are aware of their rights and responsibilities in clinical trials. This study explored participants' perceptions, experiences and the factors motivating their participation in a COVID-19 vaccine trial in South Africa. METHODS: This descriptive qualitative study was conducted among twenty-five adult participants (18 to 64 years old) who participated in a COVID-19 vaccine trial in South Africa. Three focus group discussions and fifteen semi-structured interviews were carried out. Data were collected at a Clinical Research Site located in Prince Mshiyeni Memorial Hospital, in Umlazi Township, Durban, South Africa, where the COVID-19 vaccine trial participants were initially enrolled. Data were analysed iteratively using a thematic analysis approach. RESULTS: Four key findings emerged: 1) Participants who experienced an event (such as tested positive for COVID-19) during the clinical trial were more likely to talk about the informed consent more thoroughly compared to the other participants. 2) Participants understood the purpose of informed consent process better when it was repeated multiple times throughout the course of the trial. 3) Where participants did not recall or understand various elements of the informed consent, participants were likely to create their own interpretations. 4) Factors influencing participations in trials were reimbursement for participation, access to health care, protection of family members, and ability to socialize without fear of COVID-19. CONCLUSION: Overall, the findings show that the informed consent process should be regarded as an ongoing process rather than a once-off event that only happens at the start of a clinical trial. An understanding of participants' perspectives, experiences, and motivations for participating in clinical trials, can help trial staff strengthen the consent documents and processes.
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BACKGROUND: The Global Evidence, Local Adaptation (GELA) project aims to maximise the impact of research on poverty-related diseases by increasing researchers' and decision-makers' capacity to use global research to develop locally relevant guidelines for newborn and child health in Malawi, Nigeria and South Africa. To facilitate ongoing collaboration with stakeholders, we adopted an Integrated Knowledge Translation (IKT) approach within GELA. Given limited research on IKT in African settings, we documented our team's IKT capacity and skills, and process and experiences with developing and implementing IKT in these countries. METHODS: Six IKT champions and a coordinator formed the GELA IKT Working Group. We gathered data on our baseline IKT competencies and processes within GELA, and opportunities, challenges and lessons learned, from April 2022 to March 2023 (Year 1). Data was collected from five two-hour Working Group meetings (notes, presentation slides and video recordings); [2] process documents (flowcharts and templates); and [3] an open-ended questionnaire. Data was analysed using a thematic analysis approach. RESULTS: Three overarching themes were identified: [1] IKT approach applied within GELA [2], the capacity and motivations of IKT champions, and [3] the experiences with applying the GELA IKT approach in the three countries. IKT champions and country teams adopted an iterative approach to carry out a comprehensive mapping of stakeholders, determine stakeholders' level of interest in and influence on GELA using the Power-Interest Matrix, and identify realistic indicators for monitoring the country-specific strategies. IKT champions displayed varying capacities, strong motivation, and they engaged in skills development activities. Country teams leveraged existing relationships with their National Ministries of Health to drive responses and participation by other stakeholders, and adopted variable communication modes (e.g. email, phone calls, social media) for optimal engagement. Flexibility in managing competing interests and priorities ensured optimal participation by stakeholders, although the time and resources required by IKT champions were frequently underestimated. CONCLUSIONS: The intentional, systematic, and contextualized IKT approach carried out in the three African countries within GELA, provides important insights for enhancing the implementation, feasibility and effectiveness of other IKT initiatives in Africa and similar low- and middle-income country (LMIC) settings.
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Pesquisa Translacional Biomédica , Humanos , África do Sul , Malaui , Nigéria , Pesquisa Translacional Biomédica/organização & administração , Recém-Nascido , Fortalecimento InstitucionalRESUMO
BACKGROUND: Climate Change (CC) emanating from anthropocentric human activities is a great threat to the quality of human life and well-being worldwide. The translation of CC research evidence can play a critical role in promoting the formulation of climate-sensitive policies to equip public health systems for CC-associated disaster preparedness, response, and management. This scoping review seeks to explore knowledge translation approaches for promoting, the uptake, and use of CC research evidence in public health policy and practice. METHODS: This scoping review will be conducted according to the guidelines of Arksey and O'Malley. A search strategy will be developed for published articles in PubMed, CINAHL, and Scopus databases and for grey literature in the World Health Organization, Planetary Health Alliance, and the University of the Western Cape repositories. DISCUSSION: The proposed scoping review will gather existing evidence on the relationship between knowledge translation, CC research, and public health decision-making. This will provide insights into research and practice gaps, and recommendations will be made to ensure effective knowledge translation for CC related decision-making.
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Mudança Climática , Política Pública , Humanos , Projetos de Pesquisa , Política de Saúde , Literatura de Revisão como AssuntoRESUMO
BACKGROUND: Integrated knowledge translation (IKT) through strategic, continuous engagement with decision-makers represents an approach to bridge research, policy and practice. The Collaboration for Evidence-based Healthcare and Public Health in Africa (CEBHA +), comprising research institutions in Ethiopia, Malawi, Rwanda, South Africa, Uganda and Germany, developed and implemented tailored IKT strategies as part of its multifaceted research on prevention and care of non-communicable diseases and road traffic injuries. The objective of this article is to describe the CEBHA + IKT approach and report on the development, implementation and monitoring of site-specific IKT strategies. METHODS: We draw on findings derived from the mixed method IKT evaluation (conducted in 2020-2021), and undertook document analyses and a reflective survey among IKT implementers. Quantitative data were analysed descriptively and qualitative data were analysed using content analysis. The authors used the TIDieR checklist to report results in a structured manner. RESULTS: Preliminary IKT evaluation data (33 interviews with researchers and stakeholders from policy and practice, and 31 survey responses), 49 documents, and eight responses to the reflective survey informed this article. In each of the five African CEBHA + countries, a site-specific IKT strategy guided IKT implementation, tailored to the respective national context, engagement aims, research tasks, and individuals involved. IKT implementers undertook a variety of IKT activities at varying levels of engagement that targeted a broad range of decision-makers and other stakeholders, particularly during project planning, data interpretation, and output dissemination. Throughout the project, the IKT teams continued to tailor IKT strategies informally and modified the IKT approach by responding to ad hoc engagements and involving non-governmental organisations, universities, and communities. Challenges to using systematic, formalised IKT strategies arose in particular with respect to the demand on time and resources, leading to the modification of monitoring processes. CONCLUSION: Tailoring of the CEBHA + IKT approach led to the inclusion of some atypical IKT partners and to greater responsiveness to unexpected opportunities for decision-maker engagement. Benefits of using systematic IKT strategies included clarity on engagement aims, balancing of existing and new strategic partnerships, and an enhanced understanding of research context, including site-specific structures for evidence-informed decision-making.
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Lista de Checagem , Ciência Translacional Biomédica , Humanos , Confiabilidade dos Dados , Análise Documental , EtiópiaRESUMO
Knowledge translation (KT) is a set of activities or processes for synthesising, disseminating, and applying research evidence in decision-making for the benefit of society. For KT to be successful, it is paramount for researchers to play an active role in encouraging evidence uptake and use in decision-making. We carried out a mapping exercise and interviews with research cluster heads at Cochrane South Africa (CSA) of the KT activities and processes being implemented (or are planned for implementation). We organized the mapping and interview results according to the KT themes described in the Cochrane KT framework. The KT framework comprises six themes, namely, (i) prioritization and co-production of research evidence; (ii) building a sustainable infrastructure for knowledge translation; (iii) engaging with audiences for knowledge exchange or dialogue; (iv) packaging, communication and dissemination which entails disseminating research to users; (v) building audience capacity to use evidence or training activities; and (vi) advocacy or improving the culture of using evidence. Through the mapping exercise and interviews, we learned that CSA researchers excelled in implementing activities and processes linked to most of the KT themes, including producing different types of systematic reviews and providing reliable evidence for health decision-making. Cochrane South Africa (CSA) researchers are also involved in mentoring and training postgraduate students and various health decision-makers (e.g., health professionals, guideline panels and policy-makers). While they excel in the above-mentioned activities, "packaging, communication, and dissemination of research evidence" (theme iv) was identified as an area of improvement.
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Pessoal Administrativo , Ciência Translacional Biomédica , Humanos , África do Sul , Revisões Sistemáticas como Assunto , ComunicaçãoRESUMO
BACKGROUND: Noncommunicable diseases are major contributors to morbidity and mortality worldwide. Modifying the risk factors for these conditions, such as physical inactivity, is thus essential. Addressing the context or circumstances in which physical activity occurs may promote physical activity at a population level. We assessed the effects of infrastructure, policy or regulatory interventions for increasing physical activity. METHODS: We searched PubMed, Embase and clinicaltrials.gov to identify randomised controlled trials (RCTs), controlled before-after (CBAs) studies, and interrupted time series (ITS) studies assessing population-level infrastructure or policy and regulatory interventions to increase physical activity. We were interested in the effects of these interventions on physical activity, body weight and related measures, blood pressure, and CVD and type 2 diabetes morbidity and mortality, and on other secondary outcomes. Screening and data extraction was done in duplicate, with risk of bias was using an adapted Cochrane risk of bias tool. Due to high levels of heterogeneity, we synthesised the evidence based on effect direction. RESULTS: We included 33 studies, mostly conducted in high-income countries. Of these, 13 assessed infrastructure changes to green or other spaces to promote physical activity and 18 infrastructure changes to promote active transport. The effects of identified interventions on physical activity, body weight and blood pressure varied across studies (very low certainty evidence); thus, we remain very uncertain about the effects of these interventions. Two studies assessed the effects of policy and regulatory interventions; one provided free access to physical activity facilities and showed that it may have beneficial effects on physical activity (low certainty evidence). The other provided free bus travel for youth, with intervention effects varying across studies (very low certainty evidence). CONCLUSIONS: Evidence from 33 studies assessing infrastructure, policy and regulatory interventions for increasing physical activity showed varying results. The certainty of the evidence was mostly very low, due to study designs included and inconsistent findings between studies. Despite this drawback, the evidence indicates that providing access to physical activity facilities may be beneficial; however this finding is based on only one study. Implementation of these interventions requires full consideration of contextual factors, especially in low resource settings. TRIAL REGISTRATION: PROSPERO 2018 CRD42018093429.
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Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Exercício Físico , Adolescente , Humanos , Peso Corporal , Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus Tipo 2/prevenção & controle , PolíticasRESUMO
INTRODUCTION: Knowledge translation platforms (KTPs) are intermediary organisations, initiatives or networks whose intent is to bridge the evidence into action divide. Strategies and tools include collaborative knowledge production, capacity building, information exchange and dialogue to facilitate relevant and timely engagement between researchers and decision-makers and other relevant stakeholders. With the wide range of definitions and descriptions of KTPs, there is a need to (1) provide a nuanced understanding of characteristics of KTPs and (2) assess and consolidate research methods used in mapping and evaluating KTPs to inform standardised process and impact evaluation. METHODS AND ANALYSIS: This scoping review will follow the recommended and accepted methods for scoping reviews and reporting guidelines. Eligibility for inclusion is any conceptual or empirical health-related qualitative, quantitative and/or mixed method studies including (1) definitions, descriptions and models or frameworks of KTPs (including those that do not self-identify as KTPs, eg, university research centres) and (2) research methods for mapping and/or evaluating KTPs. Searches will be carried out in PubMed, Scopus, CINAHL, Embase, Global Health and Web of Science using a predetermined search strategy, without any date, language or geographical restrictions. Two reviewers will independently screen titles and abstracts. One reviewer will complete data extraction for all included studies, and another will check a sample of 50% of the included studies. The analysis and synthesis will provide (1) an understanding of the various characteristics of KTPs; (2) insight into characteristics or factors that make them resilient and/or adaptive to facilitate impact (ie, influence policy and practice); and (3) an overview of the various methods for mapping and evaluating KTPs. We will explore enhancing an existing framework for classifying KTPs, or perhaps even developing a new framework for identifying and monitoring KTPs if necessary and relevant. ETHICS AND DISSEMINATION: This scoping review does not require ethics approval, as we will only include information from previously conducted studies and we will not involve human participants. The results will be submitted to a peer-reviewed scientific journal for publication and as conference presentations.
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Projetos de Pesquisa , Ciência Translacional Biomédica , Humanos , Conhecimento , Literatura de Revisão como AssuntoRESUMO
BACKGROUND: Programmes that introduce rapid molecular tests for tuberculosis and tuberculosis drug resistance aim to bring tests closer to the community, and thereby cut delay in diagnosis, ensure early treatment, and improve health outcomes, as well as overcome problems with poor laboratory infrastructure and inadequately trained personnel. Yet, diagnostic technologies only have an impact if they are put to use in a correct and timely manner. Views of the intended beneficiaries are important in uptake of diagnostics, and their effective use also depends on those implementing testing programmes, including providers, laboratory professionals, and staff in health ministries. Otherwise, there is a risk these technologies will not fit their intended use and setting, cannot be made to work and scale up, and are not used by, or not accessible to, those in need. OBJECTIVES: To synthesize end-user and professional user perspectives and experiences with low-complexity nucleic acid amplification tests (NAATs) for detection of tuberculosis and tuberculosis drug resistance; and to identify implications for effective implementation and health equity. SEARCH METHODS: We searched MEDLINE, Embase, CINAHL, PsycInfo and Science Citation Index Expanded databases for eligible studies from 1 January 2007 up to 20 October 2021. We limited all searches to 2007 onward because the development of Xpert MTB/RIF, the first rapid molecular test in this review, was completed in 2009. SELECTION CRITERIA: We included studies that used qualitative methods for data collection and analysis, and were focused on perspectives and experiences of users and potential users of low-complexity NAATs to diagnose tuberculosis and drug-resistant tuberculosis. NAATs included Xpert MTB/RIF, Xpert MTB/RIF Ultra, Xpert MTB/XDR, and the Truenat assays. Users were people with presumptive or confirmed tuberculosis and drug-resistant tuberculosis (including multidrug-resistant (MDR-TB)) and their caregivers, healthcare providers, laboratory technicians and managers, and programme officers and staff; and were from any type of health facility and setting globally. MDR-TB is tuberculosis caused by resistance to at least rifampicin and isoniazid, the two most effective first-line drugs used to treat tuberculosis. DATA COLLECTION AND ANALYSIS: We used a thematic analysis approach for data extraction and synthesis, and assessed confidence in the findings using GRADE CERQual approach. We developed a conceptual framework to illustrate how the findings relate. MAIN RESULTS: We found 32 studies. All studies were conducted in low- and middle-income countries. Twenty-seven studies were conducted in high-tuberculosis burden countries and 21 studies in high-MDR-TB burden countries. Only one study was from an Eastern European country. While the studies covered a diverse use of low-complexity NAATs, in only a minority of studies was it used as the initial diagnostic test for all people with presumptive tuberculosis. We identified 18 review findings and grouped them into three overarching categories. Critical aspects users value People with tuberculosis valued reaching diagnostic closure with an accurate diagnosis, avoiding diagnostic delays, and keeping diagnostic-associated cost low. Similarly, healthcare providers valued aspects of accuracy and the resulting confidence in low-complexity NAAT results, rapid turnaround times, and keeping cost to people seeking a diagnosis low. In addition, providers valued diversity of sample types (for example, gastric aspirate specimens and stool in children) and drug resistance information. Laboratory professionals appreciated the improved ease of use, ergonomics, and biosafety of low-complexity NAATs compared to sputum microscopy, and increased staff satisfaction. Challenges reported to realizing those values People with tuberculosis and healthcare workers were reluctant to test for tuberculosis (including MDR-TB) due to fears, stigma, or cost concerns. Thus, low-complexity NAAT testing is not implemented with sufficient support or discretion to overcome barriers that are common to other approaches to testing for tuberculosis. Delays were reported at many steps of the diagnostic pathway owing to poor sample quality; difficulties with transporting specimens; lack of sufficient resources; maintenance of low-complexity NAATs; increased workload; inefficient work and patient flows; over-reliance on low-complexity NAAT results in lieu of clinical judgement; and lack of data-driven and inclusive implementation processes. These challenges were reported to lead to underutilization. Concerns for access and equity The reported concerns included sustainable funding and maintenance and equitable use of resources to access low-complexity NAATs, as well as conflicts of interest between donors and people implementing the tests. Also, lengthy diagnostic delays, underutilization of low-complexity NAATs, lack of tuberculosis diagnostic facilities in the community, and too many eligibility restrictions hampered access to prompt and accurate testing and treatment. This was particularly the case for vulnerable groups, such as children, people with MDR-TB, or people with limited ability to pay. We had high confidence in most of our findings. AUTHORS' CONCLUSIONS: Low-complexity diagnostics have been presented as a solution to overcome deficiencies in laboratory infrastructure and lack of skilled professionals. This review indicates this is misleading. The lack of infrastructure and human resources undermine the added value new diagnostics of low complexity have for recipients and providers. We had high confidence in the evidence contributing to these review findings. Implementation of new diagnostic technologies, like those considered in this review, will need to tackle the challenges identified in this review including weak infrastructure and systems, and insufficient data on ground level realities prior and during implementation, as well as problems of conflicts of interest in order to ensure equitable use of resources.
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Tuberculose Resistente a Múltiplos Medicamentos , Tuberculose , Criança , Resistência a Medicamentos , Humanos , Técnicas de Amplificação de Ácido Nucleico , Rifampina/uso terapêutico , Tuberculose/diagnóstico , Tuberculose/tratamento farmacológico , Tuberculose Resistente a Múltiplos Medicamentos/diagnóstico , Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológicoRESUMO
BACKGROUND: Childhood vaccination is one of the most effective ways to prevent serious illnesses and deaths in children. However, worldwide, many children do not receive all recommended vaccinations, for several potential reasons. Vaccines might be unavailable, or parents may experience difficulties in accessing vaccination services; for instance, because of poor quality health services, distance from a health facility, or lack of money. Some parents may not accept available vaccines and vaccination services. Our understanding of what influences parents' views and practices around childhood vaccination, and why some parents may not accept vaccines for their children, is still limited. This synthesis links to Cochrane Reviews of the effectiveness of interventions to improve coverage or uptake of childhood vaccination. OBJECTIVES: - Explore parents' and informal caregivers' views and practices regarding routine childhood vaccination, and the factors influencing acceptance, hesitancy, or nonacceptance of routine childhood vaccination. - Develop a conceptual understanding of what and how different factors reduce parental acceptance of routine childhood vaccination. - Explore how the findings of this review can enhance our understanding of the related Cochrane Reviews of intervention effectiveness. SEARCH METHODS: We searched MEDLINE, Embase, CINAHL, and three other databases for eligible studies from 1974 to June 2020. SELECTION CRITERIA: We included studies that: utilised qualitative methods for data collection and analysis; focused on parents' or caregivers' views, practices, acceptance, hesitancy, or refusal of routine vaccination for children aged up to six years; and were from any setting globally where childhood vaccination is provided. DATA COLLECTION AND ANALYSIS: We used a pre-specified sampling frame to sample from eligible studies, aiming to capture studies that were conceptually rich, relevant to the review's phenomenon of interest, from diverse geographical settings, and from a range of income-level settings. We extracted contextual and methodological data from each sampled study. We used a meta-ethnographic approach to analyse and synthesise the evidence. We assessed methodological limitations using a list of criteria used in previous Cochrane Reviews and originally based on the Critical Appraisal Skills Programme quality assessment tool for qualitative studies. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in each finding. We integrated the findings of this review with those from relevant Cochrane Reviews of intervention effectiveness. We did this by mapping whether the underlying theories or components of trial interventions included in those reviews related to or targeted the overarching factors influencing parental views and practices regarding routine childhood vaccination identified by this review. MAIN RESULTS: We included 145 studies in the review and sampled 27 of these for our analysis. Six studies were conducted in Africa, seven in the Americas, four in South-East Asia, nine in Europe, and one in the Western Pacific. Studies included urban and rural settings, and high-, middle-, and low-income settings. Many complex factors were found to influence parents' vaccination views and practices, which we divided into four themes. Firstly, parents' vaccination ideas and practices may be influenced by their broader ideas and practices surrounding health and illness generally, and specifically with regards to their children, and their perceptions of the role of vaccination within this context. Secondly, many parents' vaccination ideas and practices were influenced by the vaccination ideas and practices of the people they mix with socially. At the same time, shared vaccination ideas and practices helped some parents establish social relationships, which in turn strengthened their views and practices around vaccination. Thirdly, parents' vaccination ideas and practices may be influenced by wider political issues and concerns, and particularly their trust (or distrust) in those associated with vaccination programmes. Finally, parents' vaccination ideas and practices may be influenced by their access to and experiences of vaccination services and their frontline healthcare workers. We developed two concepts for understanding possible pathways to reduced acceptance of childhood vaccination. The first concept, 'neoliberal logic', suggests that many parents, particularly from high-income countries, understood health and healthcare decisions as matters of individual risk, choice, and responsibility. Some parents experienced this understanding as in conflict with vaccination programmes, which emphasise generalised risk and population health. This perceived conflict led some parents to be less accepting of vaccination for their children. The second concept, 'social exclusion', suggests that some parents, particularly from low- and middle-income countries, were less accepting of childhood vaccination due to their experiences of social exclusion. Social exclusion may damage trustful relationships between government and the public, generate feelings of isolation and resentment, and give rise to demotivation in the face of public services that are poor quality and difficult to access. These factors in turn led some parents who were socially excluded to distrust vaccination, to refuse vaccination as a form of resistance or a way to bring about change, or to avoid vaccination due to the time, costs, and distress it creates. Many of the overarching factors our review identified as influencing parents' vaccination views and practices were underrepresented in the interventions tested in the four related Cochrane Reviews of intervention effectiveness. AUTHORS' CONCLUSIONS: Our review has revealed that parents' views and practices regarding childhood vaccination are complex and dynamic social processes that reflect multiple webs of influence, meaning, and logic. We have provided a theorised understanding of the social processes contributing to vaccination acceptance (or not), thereby complementing but also extending more individualistic models of vaccination acceptance. Successful development of interventions to promote acceptance and uptake of childhood vaccination will require an understanding of, and then tailoring to, the specific factors influencing vaccination views and practices of the group(s) in the target setting. The themes and concepts developed through our review could serve as a basis for gaining this understanding, and subsequent development of interventions that are potentially more aligned with the norms, expectations, and concerns of target users.
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Cuidadores , Pais , Criança , Pessoal de Saúde , Humanos , Pesquisa Qualitativa , VacinaçãoRESUMO
BACKGROUND: Evidence-informed clinical practice guidelines (CPGs) are useful tools to inform transparent healthcare decision-making. Consideration of health economic evidence (HEE) during CPG development in a structured manner remains a challenge globally and locally. This study explored the views, current practice, training needs and challenges faced by CPG developers in the production and use of HEE for CPGs in South Africa. METHODS: This mixed-methods study comprised an online survey and a focus group discussion. The survey was piloted and subsequently sent to CPG role players - evidence reviewers, CPG panellists, academics involved with training in relevant disciplines like health economics and public health, implementers and funders. The focus group participants hold strategic roles in CPG development and health economic activities nationally. The survey evaluated mean values, measures of variability, and percentages for Likert scales, while narrative components were thematically analysed. Focus group data were manually coded, thematically analysed and verified. RESULTS: The survey (n = 55 respondents to 245 surveys distributed) and one focus group (n = 5 participants from 10 people invited) occurred between October 2018 and February 2019. We found the most consistent reason why HEE should inform CPG decisions was 'making more efficient use of limited financial resources'. This was explained by numerous context and methodological barriers. Focus groups participants noted that consideration of complex HEE are not achievable without bolstering skills in applying evidence-based medicine principles. Further concerns include lack of clarity of standard methods; inequitable and opaque topic selection across private and public sectors; inadequate skills of CPG panel members to use HEE; and the ability of health economists to communicate results in accessible ways. Overall, in the absence of clarity about process and methods, politics and interests may drive CPG decisions about which interventions to implement. CONCLUSIONS: HEE should ideally be considered in CPG decisions in South Africa. However, this will remain hampered until the CPG community agree on methods and processes for using HEE in CPGs. Focused investment by national government to address the challenges identified by the study is imperative for a better return on investment as National Health Insurance moves forward.
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Economia Médica , Medicina Baseada em Evidências , Governo Federal , Humanos , Programas Nacionais de Saúde , África do SulRESUMO
BACKGROUND: In response to the "know-do" gap, several initiatives have been implemented to enhance evidence-informed decision-making (EIDM). These include individual training, organizational culture change management, and legislative changes. The importance of relationships and stakeholder engagement in EIDM has led to an evolution of models and approaches including integrated knowledge translation (IKT). IKT has emerged as a key strategy for ensuring that engagement is equitable, demand-driven, and responsive. As a result, the African-German Collaboration for Evidence-Based Healthcare and Public Health in Africa (CEBHA+) incorporated an IKT approach to influence noncommunicable diseases (NCD) policy and practice. We documented the phased process of developing, implementing, and monitoring the IKT approach in South Africa; and explored the appropriateness of using the exploration, preparation, implementation, and sustainment (EPIS) framework for this purpose. METHODS: We mapped the South Africa IKT approach onto the EPIS framework using a framework analysis approach. Notes of team meetings, stakeholder matrices, and engagement strategies were analysed and purposefully plotted against the four phases of the framework in order to populate the different constructs. We discussed and finalized the analysis in a series of online iterations until consensus was reached. RESULTS: The mapping exercise revealed an IKT approach that was much more iterative, dynamic, and engaging than initially thought. Several constructs (phase-agnostic) remained important and stable across EPIS phases: stable and supportive funding; committed and competent leadership; skilled and dedicated IKT champions; diverse and established personal networks; a conducive and enabling policy environment; and boundary-spanning intermediaries. Constructs such as "innovations" constantly evolved and adapted to the changing inner and outer contexts (phase-specific). CONCLUSIONS: Using the EPIS framework to interrogate, reflect on, and document our IKT experiences proved extremely relevant and useful. Phase-agnostic constructs proved critical to ensure resilience and agility of NCD deliberations and policies in the face of highly dynamic and changing local contexts, particularly in view of the current coronavirus disease 2019 (COVID-19) pandemic. Bridging IKT with a framework from implementation science helps to reflect on this process and can guide the development and planning of similar interventions and strategies.
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COVID-19 , Doenças não Transmissíveis , Humanos , Doenças não Transmissíveis/terapia , Políticas , SARS-CoV-2 , África do Sul , Pesquisa Translacional BiomédicaRESUMO
BACKGROUND: The Collaboration for Evidence-based Healthcare and Public Health in Africa (CEBHA+) is a research consortium concerned with the prevention, diagnosis and treatment of non-communicable diseases. CEBHA+ seeks to engage policymakers and practitioners throughout the research process in order to build lasting relationships, enhance evidence uptake, and create long-term capacity among partner institutions in Ethiopia, Malawi, Rwanda, South Africa and Uganda in collaboration with two German universities. This integrated knowledge translation (IKT) approach includes the formal development, implementation and evaluation of country specific IKT strategies. METHODS: We have conceptualised the CEBHA+ IKT approach as a complex intervention in a complex system. We will employ a comparative case study (CCS) design and mixed methods to facilitate an in-depth evaluation. We will use quantitative surveys, qualitative interviews, quarterly updates, and a policy document analysis to capture the process and outcomes of IKT across the African CEBHA+ partner sites. We will conduct an early stage (early 2020) and a late-stage evaluation (early 2022), triangulate the data collected with various methods at each site and subsequently compare our findings across the five sites. DISCUSSION: Evaluating a complex intervention such as the CEBHA+ IKT approach is complicated, even more so when undertaken across five diverse countries. Despite conceptual, methodological and practical challenges, our comparative case study addresses important evidence gaps: While involving decision-makers in the research process is gaining traction worldwide, we still know very little regarding (i) whether this approach really makes a difference to evidence uptake, (ii) the mechanisms that make IKT successful, and (iii) relevant differences across socio-cultural contexts. The evaluation described here is intended to provide relevant insights on all of these aspects, notably in countries in Sub-Saharan Africa, and is expected to contribute to the science of IKT overall.
Assuntos
Doenças não Transmissíveis/prevenção & controle , Projetos de Pesquisa , Pesquisa Translacional Biomédica , África , Atenção à Saúde , Alemanha , Pesquisa sobre Serviços de Saúde , Humanos , Estudos Multicêntricos como Assunto , Saúde PúblicaRESUMO
The current standards for detecting active coronavirus disease (COVID-19) infection are molecular tests by reverse transcription polymerase chain reaction, using swabs from the lower or upper respiratory tract. Because of the expertise required and the long turnaround time for the availability of test results, faster and easier point-of-care methods are necessary. The latter may include the detection of antibodies specific to COVID-19. We highlight a recent Cochrane review that assessed the accuracy of antibody tests for diagnosing COVID-19. The review shows that, at present, antibodies have little use in the diagnosis of COVID-19 within the first seven days from onset of symptoms. However, as time progresses, the sensitivity of the antibody tests increases. Antibody tests are more useful in detecting previous COVID-19 infection if used 15 days or more from onset of symptoms. Data presented in the review should be interpreted with caution as most studies (85%) recruited in-hospital patients and 11% recruited suspected COVID-19 patients, while only 4% recruited convalescent patients. This limits generalisability of the results to most settings.
Assuntos
Teste Sorológico para COVID-19 , COVID-19/diagnóstico , Humanos , Sensibilidade e EspecificidadeRESUMO
BACKGROUND: Data harmonisation (DH) has emerged amongst health managers, information technology specialists and researchers as an important intervention for routine health information systems (RHISs). It is important to understand what DH is, how it is defined and conceptualised, and how it can lead to better health management decision-making. This scoping review identifies a range of definitions for DH, its characteristics (in terms of key components and processes), and common explanations of the relationship between DH and health management decision-making. METHODS: This scoping review identified relevant studies from 2000 onwards (date filter), written in English and published in PubMed, Web of Science and CINAHL. Two reviewers independently screened records for potential inclusion for the abstract and full-text screening stages. One reviewer did the data extraction, analysis and synthesis, with built-in reliability checks from the rest of the team. We developed a narrative synthesis of definitions and explanations of the relationship between DH and health management decision-making. RESULTS: We sampled 61 of 181 included to synthesis definitions and concepts of DH in detail. We identified six common terms for data harmonisation: record linkage, data linkage, data warehousing, data sharing, data interoperability and health information exchange. We also identified nine key components of data harmonisation: DH involves (a) a process of multiple steps; (b) integrating, harmonising and bringing together different databases (c) two or more databases; (d) electronic data; (e) pooling data using unique patient identifiers; and (f) different types of data; (g) data found within and across different departments and institutions at facility, district, regional and national levels; (h) different types of technical activities; (i) has a specific scope. The relationship between DH and health management decision-making is not well-described in the literature. Several studies mentioned health providers' concerns about data completeness, data quality, terminology and coding of data elements as barriers to data utilisation for clinical decision-making. CONCLUSION: To our knowledge, this scoping review was the first to synthesise definitions and concepts of DH and address the causal relationship between DH and health management decision-making. Future research is required to assess the effectiveness of data harmonisation on health management decision-making.
Assuntos
Troca de Informação em Saúde , Sistemas de Informação em Saúde , Atenção à Saúde , Humanos , Armazenamento e Recuperação da Informação , Reprodutibilidade dos TestesRESUMO
BACKGROUND: After decades of decline since 2005, the global prevalence of undernourishment reverted and since 2015 has increased to levels seen in 2010 to 2011. The prevalence is highest in low- and middle-income countries (LMICs), especially Africa and Asia. Food insecurity and associated undernutrition detrimentally affect health and socioeconomic development in the short and long term, for individuals, including children, and societies. Physical and economic access to food is crucial to ensure food security. Community-level interventions could be important to increase access to food in LMICs. OBJECTIVES: To determine the effects of community-level interventions that aim to improve access to nutritious food in LMICs, for both the whole community and for disadvantaged or at-risk individuals or groups within a community, such as infants, children and women; elderly, poor or unemployed people; or minority groups. SEARCH METHODS: We searched for relevant studies in 16 electronic databases, including trial registries, from 1980 to September 2019, and updated the searches in six key databases in February 2020. We applied no language or publication status limits. SELECTION CRITERIA: We included randomised controlled trials (RCTs), cluster randomised controlled trials (cRCTs) and prospective controlled studies (PCS). All population groups, adults and children, living in communities in LMICs exposed to community-level interventions aiming to improve food access were eligible for inclusion. We excluded studies that only included participants with specific diseases or conditions (e.g. severely malnourished children). Eligible interventions were broadly categorised into those that improved buying power (e.g. create income-generation opportunities, cash transfer schemes); addressed food prices (e.g. vouchers and subsidies); addressed infrastructure and transport that affected physical access to food outlets; addressed the social environment and provided social support (e.g. social support from family, neighbours or government). DATA COLLECTION AND ANALYSIS: Two authors independently screened titles and abstracts, and full texts of potentially eligible records, against the inclusion criteria. Disagreements were resolved through discussion or arbitration by a third author, if necessary. For each included study, two authors independently extracted data and a third author arbitrated disagreements. However, the outcome data were extracted by one author and checked by a biostatistician. We assessed risk of bias for all studies using the Effective Practice and Organization of Care (EPOC) risk of bias tool for studies with a separate control group. We conducted meta-analyses if there was a minimum of two studies for interventions within the same category, reporting the same outcome measure and these were sufficiently homogeneous. Where we were able to meta-analyse, we used the random-effects model to incorporate any existing heterogeneity. Where we were unable to conduct meta-analyses, we synthesised using vote counting based on effect direction. MAIN RESULTS: We included 59 studies, including 214 to 169,485 participants, and 300 to 124, 644 households, mostly from Africa and Latin America, addressing the following six intervention types (three studies assessed two different types of interventions). Interventions that improved buying power: Unconditional cash transfers (UCTs) (16 cRCTs, two RCTs, three PCSs): we found high-certainty evidence that UCTs improve food security and make little or no difference to cognitive function and development and low-certainty evidence that UCTs may increase dietary diversity and may reduce stunting. The evidence was very uncertain about the effects of UCTs on the proportion of household expenditure on food, and on wasting. Regarding adverse outcomes, evidence from one trial indicates that UCTs reduce the proportion of infants who are overweight. Conditional cash transfers (CCTs) (nine cRCTs, five PCSs): we found high-certainty evidence that CCTs result in little to no difference in the proportion of household expenditure on food and that they slightly improve cognitive function in children; moderate-certainty evidence that CCTs probably slightly improve dietary diversity and low-certainty evidence that they may make little to no difference to stunting or wasting. Evidence on adverse outcomes (two PCSs) shows that CCTs make no difference to the proportion of overweight children. Income generation interventions (six cRCTs, 11 PCSs): we found moderate-certainty evidence that income generation interventions probably make little or no difference to stunting or wasting; and low-certainty evidence that they may result in little to no difference to food security or that they may improve dietary diversity in children, but not for households. Interventions that addressed food prices: Food vouchers (three cRCTs, one RCT): we found moderate-certainty evidence that food vouchers probably reduce stunting; and low-certainty evidence that that they may improve dietary diversity slightly, and may result in little to no difference in wasting. Food and nutrition subsidies (one cRCT, three PCSs): we found low-certainty evidence that food and nutrition subsidies may improve dietary diversity among school children. The evidence is very uncertain about the effects on household expenditure on healthy foods as a proportion of total expenditure on food (very low-certainty evidence). Interventions that addressed the social environment: Social support interventions (one cRCT, one PCS): we found moderate-certainty evidence that community grants probably make little or no difference to wasting; low-certainty evidence that they may make little or no difference to stunting. The evidence is very uncertain about the effects of village savings and loans on food security and dietary diversity. None of the included studies addressed the intervention category of infrastructure changes. In addition, none of the studies reported on one of the primary outcomes of this review, namely prevalence of undernourishment. AUTHORS' CONCLUSIONS: The body of evidence indicates that UCTs can improve food security. Income generation interventions do not seem to make a difference for food security, but the evidence is unclear for the other interventions. CCTs, UCTs, interventions that help generate income, interventions that help minimise impact of food prices through food vouchers and subsidies can potentially improve dietary diversity. UCTs and food vouchers may have a potential impact on reducing stunting, but CCTs, income generation interventions or social environment interventions do not seem to make a difference on wasting or stunting. CCTs seem to positively impact cognitive function and development, but not UCTs, which may be due to school attendance, healthcare visits and other conditionalities associated with CCTs.
Assuntos
Participação da Comunidade/economia , Países em Desenvolvimento , Assistência Alimentar/economia , Abastecimento de Alimentos/economia , Renda , Desnutrição/prevenção & controle , Adulto , Criança , Cognição , Participação da Comunidade/métodos , Dieta , Abastecimento de Alimentos/métodos , Transtornos do Crescimento/prevenção & controle , Humanos , Desnutrição/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Apoio Social , Síndrome de Emaciação/prevenção & controleRESUMO
BACKGROUND: A well-functioning routine health information system (RHIS) can provide the information needed for health system management, for governance, accountability, planning, policy making, surveillance and quality improvement, but poor information support has been identified as a major obstacle for improving health system management. OBJECTIVES: To assess the effects of interventions to improve routine health information systems in terms of RHIS performance, and also, in terms of improved health system management performance, and improved patient and population health outcomes. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE Ovid and Embase Ovid in May 2019. We searched Global Health, Ovid and PsycInfo in April 2016. In January 2020 we searched for grey literature in the Grey Literature Report and in OpenGrey, and for ongoing trials using the International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov. In October 2019 we also did a cited reference search using Web of Science, and a 'similar articles' search in PubMed. SELECTION CRITERIA: Randomised and non-randomised trials, controlled before-after studies and time-series studies comparing routine health information system interventions, with controls, in primary, hospital or community health care settings. Participants included clinical staff and management, district management and community health workers using routine information systems. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed records to identify studies for inclusion, extracted data from the included studies and assessed the risk of bias. Interventions and outcomes were too varied across studies to allow for pooled risk analysis. We present a 'Summary of findings' table for each intervention comparisons broadly categorised into Technical and Organisational (or a combination), and report outcomes on data quality and service quality. We used the GRADE approach to assess the certainty of the evidence. MAIN RESULTS: We included six studies: four cluster randomised trials and two controlled before-after studies, from Africa and South America. Three studies evaluated technical interventions, one study evaluated an organisational intervention, and two studies evaluated a combination of technical and organisational interventions. Four studies reported on data quality and six studies reported on service quality. In terms of data quality, a web-based electronic TB laboratory information system probably reduces the length of time to reporting of TB test results, and probably reduces the overall rate of recording errors of TB test results, compared to a paper-based system (moderate certainty evidence). We are uncertain about the effect of the electronic laboratory information system on the recording rate of serious (misidentification) errors for TB test results compared to a paper-based system (very low certainty evidence). Misidentification errors are inaccuracies in transferring test results between an electronic register and patients' clinical charts. We are also uncertain about the effect of the intervention on service quality (timeliness of starting or changing a patient's TB treatment) (very low certainty evidence). A hand-held electronic device probably improves the length of time to report TB test results, and probably reduces the total frequency of recording errors in TB test results between the laboratory notebook and the electronic information record system, compared to a paper-based system (moderate-certainty evidence). We are, however, uncertain about the effect of the intervention on the frequency of serious (misidentification) errors in recording between the laboratory notebook and the electronic information record, compared to a paper-based system (very low certainty evidence). We are uncertain about the effect of a hospital electronic health information system on service quality (length of time outpatients spend at hospital, length of hospital stay, and hospital revenue collection), compared to a paper-based system (very low certainty evidence). High-intensity brief text messaging (SMS) may make little or no difference to data quality (in terms of completeness of documentation of pregnancy outcomes), compared to low-intensity brief text messaging (low-certainty evidence). We are uncertain about the effect of electronic drug stock notification (with either data management support or product transfer support) on service quality (in terms of transporting stock and stock levels), compared to paper-based stock notification (very low certainty evidence). We are uncertain about the effect of health information strengthening (where it is part of comprehensive service quality improvement intervention) on service quality (health worker motivation, receipt of training by health workers, health information index scores, quality of clinical observation of children and adults) (very low certainty evidence). AUTHORS' CONCLUSIONS: The review indicates mixed effects of mainly technical interventions to improve data quality, with gaps in evidence on interventions aimed at enhancing data-informed health system management. There is a gap in interventions studying information support beyond clinical management, such as for human resources, finances, drug supply and governance. We need to have a better understanding of the causal mechanisms by which information support may affect change in management decision-making, to inform robust intervention design and evaluation methods.
Assuntos
Atenção à Saúde/organização & administração , Sistemas de Informação em Saúde/normas , Política Organizacional , Melhoria de Qualidade , Viés , Sistemas de Informação em Laboratório Clínico/organização & administração , Sistemas de Informação em Laboratório Clínico/normas , Computadores de Mão , Coleta de Dados/normas , Tomada de Decisões , Atenção à Saúde/normas , Serviços de Informação sobre Medicamentos/normas , Sistemas de Informação Hospitalar/normas , Testes de Sensibilidade Microbiana , Inovação Organizacional , Preparações Farmacêuticas/provisão & distribuição , Ensaios Clínicos Controlados Aleatórios como Assunto , Envio de Mensagens de Texto/normas , Tuberculose/diagnóstico , Tuberculose/tratamento farmacológicoRESUMO
BACKGROUND: There is limited evidence on whether screening for type 2 diabetes mellitus affects health outcomes. A recent systematic review of randomised clinical trials found only one trial that met their inclusion criteria; therefore, current guidelines for screening interventions for type 2 diabetes mellitus are based on expert opinions and best practice rather than synthesised evidence. This systematic review seeks to collate evidence from non-randomised studies to investigate the effect of screening for adults with type 2 diabetes on outcomes including diabetes-related morbidity, mortality (all-cause and diabetes-related) and harms. METHODS: This systematic review will follow Effective Practice and Organisation of Care (EPOC) guidelines for the synthesis of non-randomised studies. We will search PubMed/MEDLINE, Scopus, Web of Science, CINAHL, Academic Search Premier and Health Source Nursing Academic (from inception onwards). We will include non-randomised trials, controlled before-after studies, interrupted time-series studies, repeated measures studies and concurrently controlled prospective cohort studies. The primary outcome will be diabetes-related morbidity (microvascular complications of diabetic retinopathy, nephropathy or neuropathy or macrovascular complications of non-fatal myocardial infarction, peripheral arterial disease or non-fatal stroke). The secondary outcomes will be mortality (all-cause and diabetes-related) and harms of screening strategies to patients (including psychological harms or adverse events following treatments) or to health care system (including resource allocation for false-positives or overdiagnosis). Two reviewers will independently screen all citations and full-text articles. Data will be abstracted by one reviewer and checked by a second. The risk of bias of individual studies will be appraised using the ROBINS-I tool. GRADE will be used to determine the quality of the scientific evidence. If feasible, we will conduct random effects meta-analysis where appropriate. If necessary, analyses will be conducted to explore the potential sources of heterogeneity (e.g. age, sex, socio-economic status, rural versus urban or low-middle income versus high-income country). We will disseminate the findings via publications and through relevant networks. DISCUSSION: The protocol outlines the methods for systematically reviewing and synthesising evidence of screening strategies for type 2 diabetes mellitus and their effect on health outcomes associated with the disease. The potential impact of this systematic review is improved evidence-informed decision-making for policies and practice for screening of type-2 diabetes. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020147439.
Assuntos
Diabetes Mellitus Tipo 2 , Retinopatia Diabética , Adulto , Atenção à Saúde , Diabetes Mellitus Tipo 2/complicações , Humanos , Programas de Rastreamento , Metanálise como Assunto , Estudos Prospectivos , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: After decades of decline since 2005, the global prevalence of undernourishment reverted and since 2015 has increased to levels seen in 2010 to 2011. The prevalence is highest in low- and middle-income countries (LMICs), especially Africa and Asia. Food insecurity and associated undernutrition detrimentally affect health and socioeconomic development in the short and long term, for individuals, including children, and societies. Physical and economic access to food is crucial to ensure food security. Community-level interventions could be important to increase access to food in LMICs. OBJECTIVES: To determine the effects of community-level interventions that aim to improve access to nutritious food in LMICs, for both the whole community and for disadvantaged or at-risk individuals or groups within a community, such as infants, children and women; elderly, poor or unemployed people; or minority groups. SEARCH METHODS: We searched for relevant studies in 16 electronic databases, including trial registries, from 1980 to September 2019, and updated the searches in six key databases in February 2020. We applied no language or publication status limits. SELECTION CRITERIA: We included randomised controlled trials (RCTs), cluster randomised controlled trials (cRCTs) and prospective controlled studies (PCS). All population groups, adults and children, living in communities in LMICs exposed to community-level interventions aiming to improve food access were eligible for inclusion. We excluded studies that only included participants with specific diseases or conditions (e.g. severely malnourished children). Eligible interventions were broadly categorised into those that improved buying power (e.g. create income-generation opportunities, cash transfer schemes); addressed food prices (e.g. vouchers and subsidies); addressed infrastructure and transport that affected physical access to food outlets; addressed the social environment and provided social support (e.g. social support from family, neighbours or government). DATA COLLECTION AND ANALYSIS: Two authors independently screened titles and abstracts, and full texts of potentially eligible records, against the inclusion criteria. Disagreements were resolved through discussion or arbitration by a third author, if necessary. For each included study, two authors independently extracted data and a third author arbitrated disagreements. However, the outcome data were extracted by one author and checked by a biostatistician. We assessed risk of bias for all studies using the Effective Practice and Organization of Care (EPOC) risk of bias tool for studies with a separate control group. We conducted meta-analyses if there was a minimum of two studies for interventions within the same category, reporting the same outcome measure and these were sufficiently homogeneous. Where we were able to meta-analyse, we used the random-effects model to incorporate any existing heterogeneity. Where we were unable to conduct meta-analyses, we synthesised using vote counting based on effect direction. MAIN RESULTS: We included 59 studies, including 214 to 169,485 participants, and 300 to 124, 644 households, mostly from Africa and Latin America, addressing the following six intervention types (three studies assessed two different types of interventions). Interventions that improved buying power: Unconditional cash transfers (UCTs) (16 cRCTs, two RCTs, three PCSs): we found high-certainty evidence that UCTs improve food security and make little or no difference to cognitive function and development and low-certainty evidence that UCTs may increase dietary diversity and may reduce stunting. The evidence was very uncertain about the effects of UCTs on the proportion of household expenditure on food, and on wasting. Regarding adverse outcomes, evidence from one trial indicates that UCTs reduce the proportion of infants who are overweight. Conditional cash transfers (CCTs) (nine cRCTs, five PCSs): we found high-certainty evidence that CCTs result in little to no difference in the proportion of household expenditure on food and that they slightly improve cognitive function in children; moderate-certainty evidence that CCTs probably slightly improve dietary diversity and low-certainty evidence that they may make little to no difference to stunting or wasting. Evidence on adverse outcomes (two PCSs) shows that CCTs make no difference to the proportion of overweight children. Income generation interventions (six cRCTs, 11 PCSs): we found moderate-certainty evidence that income generation interventions probably make little or no difference to stunting or wasting; and low-certainty evidence that they may result in little to no difference to food security or that they may improve dietary diversity in children, but not for households. Interventions that addressed food prices: Food vouchers (three cRCTs, one RCT): we found moderate-certainty evidence that food vouchers probably reduce stunting; and low-certainty evidence that that they may improve dietary diversity slightly, and may result in little to no difference in wasting. Food and nutrition subsidies (one cRCT, three PCSs): we found low-certainty evidence that food and nutrition subsidies may improve dietary diversity among school children. The evidence is very uncertain about the effects on household expenditure on healthy foods as a proportion of total expenditure on food (very low-certainty evidence). Interventions that addressed the social environment: Social support interventions (one cRCT, one PCS): we found moderate-certainty evidence that community grants probably make little or no difference to wasting; low-certainty evidence that they may make little or no difference to stunting. The evidence is very uncertain about the effects of village savings and loans on food security and dietary diversity. None of the included studies addressed the intervention category of infrastructure changes. In addition, none of the studies reported on one of the primary outcomes of this review, namely prevalence of undernourishment. AUTHORS' CONCLUSIONS: The body of evidence indicates that UCTs can improve food security. Income generation interventions do not seem to make a difference for food security, but the evidence is unclear for the other interventions. CCTs, UCTs, interventions that help generate income, interventions that help minimise impact of food prices through food vouchers and subsidies can potentially improve dietary diversity. UCTs and food vouchers may have a potential impact on reducing stunting, but CCTs, income generation interventions or social environment interventions do not seem to make a difference on wasting or stunting. CCTs seem to positively impact cognitive function and development, but not UCTs, which may be due to school attendance, healthcare visits and other conditionalities associated with CCTs.