Randomized controlled trials in nursing conducted by Latin American research teams: A scoping review.

INTRODUCTION: Randomized controlled trials (RCTs) are the cornerstone of systematic reviews and other evidence synthesis. RCT identification remains challenging because of limitations in their indexation in major databases and potential language bias. Scientific production in Latin American nursing is steadily increasing, but little is known about its design or main features. We aimed to identify the extent of evidence from RCTs in nursing conducted by Latin American research teams and evaluate their main characteristics, including potential risk of bias. DESIGN: Scoping review with risk of bias assessment. METHODS: We conducted a scoping review including a comprehensive electronic search in five relevant databases. We completed a descriptive data analysis and a risk of bias assessment of eligible studies using Cochrane's guidance. RESULTS: We identified 1784 references of which 47 were RCTs published in 40 journals. Twenty (42.6%) RCTs were published in journals in English. Chronic diseases were the most common health conditions studied (29.7%). Fifteen (31.9%) RCTs had a high risk of bias. Thirty (75%) journals were included in the Journal Citation Report (JCR) catalog and 5 (16.7%) were journals classified under nursing category. Twenty-one (52.5%) journals explicitly required CONSORT checklist recommendations for RCTs reporting. CONCLUSION: Publication of RCTs in nursing by Latin American authors has increased. Most journals where RCTs are published are in English and not specific to nursing. Searches in journals of other disciplines may be necessary to facilitate identification of RCTs in nursing. CONSORT statements need to be actively promoted to facilitate rigorous methodology and reporting of RCTs. CLINICAL RELEVANCE STATEMENT: This study highlights the need for an increased research focus on RCTs in nursing in Latin America, and the importance of enhancing the reporting quality of these studies to support evidence-based nursing practice.

The life and death of living systematic reviews: a methodological survey.

OBJECTIVES: The objectives of this study are to describe the characteristics of living systematic reviews (LSRs) and to understand their life cycles. STUDY DESIGN AND SETTING: We conducted a comprehensive search up to April 2021 then selected articles and abstracted data in duplicate and independently. We undertook descriptive analyses and calculated delay in version update and delay since the last published version. RESULTS: We included 76 eligible LSRs with a total of 279 eligible versions. The majority of LSRs was from the clinical field (70%), was COVID-19 related (63%), and had a funding source specified (62%). The median number of versions per LSR was 2 (interquartile range (IQR) 1-4; range 1-19). The median and IQR for the ratio of the actual period of update to the planned period of update was 1.12 (0.81; 1.71). Out of all reviews with a 'planned period of update' and at least one update (N = 19), eight LSRs (42%) had a period since last published version greater than 3 times the planned period of update. No LSR included a 'retirement notice' in their latest published version. CONCLUSION: While most LSR complied with the planned period of producing updates, a substantive proportion lagged since their last update.

Stakeholder views of services for children and adolescents with obesity: Mega-ethnography of qualitative syntheses.

OBJECTIVE: The efficacy of services for children and adolescents with obesity is well researched, but this review describes what actually matters to stakeholders (children, caregivers, and professionals) in relation to such services. METHODS: A mega-ethnography, an innovative review-of-reviews approach that uses conceptual findings as primary data, was performed. Twelve bibliographic databases (2010-2020) were searched for reviews that considered the values and preferences of stakeholders concerning services or interventions (diet, exercise, lifestyle) that targeted children and adolescents with obesity. RESULTS: From 485 citations, 17 relevant reviews were identified. The synthesis found that the perceived need to address obesity is determined by subjective norms of weight and interactions with health professionals. Children's and caregivers' participation in obesity management services is shaped by their response to content, acceptability, and perceived benefits and demands. Whether they continue with and complete an intervention are determined by its perceived success, beyond just weight loss, including behavior change, enhanced self-esteem, and the provision of timely and relevant support. CONCLUSIONS: Obesity management services must be promoted in a sensitive manner and must be tailored, be varied, and make positive use of family and schools if children and caregivers are to seek and actively engage with them.

Finding and evaluating randomised controlled trials in nursing conducted by Spanish research teams: A scoping review.

BACKGROUND/OBJECTIVES: To identify and assess the main characteristics and the potential risk of bias of randomised controlled trials (RCTs) in nursing conducted by Spanish research teams. METHODS: Scoping review of an electronic search in three major databases (date of search: October 2021). For the eligible studies, both descriptive data, and data to assess the potential risk of bias, were collected and analysed. RESULTS: Of 3391 references retrieved, 199 were eligible. These RCTs were published in 122 journals, most of them in English (101, 82.1%) and were included in the Journal Citation Report (JCR) (107, 87.7%). Moreover, 32 (26.2%) of those included in the JCR were classified under nursing. Two thirds (81, 66.4%) of the journals followed the CONSORT guidelines. A total of 65 RCTs (33.7%) had a high overall risk of bias. DISCUSSION: Most of the identified RCTs were published in journals not specific to nursing and in English language. Also, shortcomings in RCT design and reporting were observed despite recommendations to adhere the CONSORT guidelines. CONCLUSION: Comprehensive identification of RCTs in nursing may require searching in journals other than nursing-related. RCTs from Spanish research teams are more likely to be published in international journals published in English. CONSORT should be strongly advised to encourage proper design and reporting of RCTs.

A Framework for the Development of Living Practice Guidelines in Health Care.

BACKGROUND: Living practice guidelines are increasingly being used to ensure that recommendations are responsive to rapidly emerging evidence. OBJECTIVE: To develop a framework that characterizes the processes of development of living practice guidelines in health care. DESIGN: First, 3 background reviews were conducted: a scoping review of methods papers, a review of handbooks of guideline-producing organizations, and an analytic review of selected living practice guidelines. Second, the core team drafted the first version of the framework. Finally, the core team refined the framework through an online survey and online discussions with a multidisciplinary international group of stakeholders. SETTING: International. PARTICIPANTS: Multidisciplinary group of 51 persons who have experience with guidelines. MEASUREMENTS: Not applicable. RESULTS: A major principle of the framework is that the unit of update in a living guideline is the individual recommendation. In addition to providing definitions, the framework addresses several processes. The planning process should address the organization's adoption of the living methodology as well as each specific guideline project. The production process consists of initiation, maintenance, and retirement phases. The reporting should cover the evidence surveillance time stamp, the outcome of reassessment of the body of evidence (when applicable), and the outcome of revisiting a recommendation (when applicable). The dissemination process may necessitate the use of different venues, including one for formal publication. LIMITATION: This study does not provide detailed or practical guidance for how the described concepts would be best implemented. CONCLUSION: The framework will help guideline developers in planning, producing, reporting, and disseminating living guideline projects. It will also help research methodologists study the processes of living guidelines. PRIMARY FUNDING SOURCE: None.

Serious reporting deficiencies exist in minimal important difference studies: current state and suggestions for improvement.

BACKGROUND AND OBJECTIVES: To evaluate reporting of minimal important difference (MID) estimates using anchor-based methods for patient-reported outcome measures (PROMs), and the association with reporting deficiencies on their credibility. METHODS: Systematic survey of primary studies empirically estimating MIDs. We searched Medline, EMBASE, PsycINFO, and the Patient-Reported Outcome and Quality of Life Instruments Database until October 2018. We evaluated study reporting, focusing on participants' demographics, intervention(s), characteristics of PROMs and anchors, and MID estimation method(s). We assessed the impact of reporting issues on credibility of MID estimates. RESULTS: In 585 studies reporting on 5,324 MID estimates for 526 distinct PROMs, authors frequently failed to adequately report key characteristics of PROMs and MIDs, including minimum and maximum values of PROM scale, measure of variability accompanying the MID estimate and number of participants included in the MID calculation. Across MID estimates (n = 5,324), the most serious reporting issues impacting credibility included infrequent reporting of the correlation between the anchor and PROM (66%), inadequate details to judge precision of MID point estimate (13%), and insufficient information about the threshold used to ascertain MIDs (16%). CONCLUSION: Serious issues of incomplete reporting in the MID literature threaten the optimal use of MID estimates to inform the magnitude of effects of interventions on PROMs.

GRADE summary of findings tables enhanced understanding of values and preferences evidence.

OBJECTIVES: We conceptualize patient values and preferences as the relative importance of health outcomes (RIO) which are often obtained through utility elicitation research. A transparent and structured approach to present synthesized RIO evidence and the certainty of this evidence is needed. This study aims to adapt the summary of findings (SoF) table to describe the RIO. STUDY DESIGN AND SETTING: We performed three interactive workshops with a protype version of the SoF table for RIO, evidence adapted from the SoF table for intervention effects. We then tested the new format through semi-structured interviews with professionals who interpret RIO evidence (e.g., systematic review authors and guideline developers). RESULTS: We adapted the SoF table for the presentation of RIO evidence. This SoF table may be easy to use, but bears one risk: some participants misunderstood the utility information and the variability around the RIO. We added a visual analogue scale to clarify the concept of utilities. CONCLUSION: Through a multi-stage process including brainstorming sessions and interviews, we adapted the SoF table to present RIO evidence. This table may enhance understanding of evidence synthesis of values and preferences, facilitating the incorporation of this type of evidence in decision-making.

Theoretical approaches to the engagement with patients in case-management programmes and assertive outreach teams: A systematic review of the literature.

WHAT IS KNOWN ON THE SUBJECT?: It is generally accepted that all interventions carried out by mental health nurses involve engagement with the patient; this engagement is a process that is gradually constructed and is not immediate. In Spain during last decade, nurses working in assertive outreach teams have gradually replaced the traditional institutional setting in favour of environments that are more familiar to the patient. In contrast, when patients and nurses interact outside institutional settings, a new approach and skillset is required in order to adapt to the new environment. WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE?: We have systematically identified and assessed the available evidence on how nurses work in assertive outreach team programmes. The therapeutic link is not just assistance; it is actually a construct, which is established between nurse and patient, with the aim of favouring, fostering and strengthening the therapeutic relationship. Only a few studies have discussed the nurse-patient therapeutic link in assertive outreach services. However, it seems important that nurses use a standardized language, that is, a language promoted as a model of correct use and used for functions of greater prestige, especially in public administration and teaching, to integrate it into the theoretical framework. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: With the synthesis that we present, we hope that it promote a more consistent use of the engagement concept in research on this topic. In turn, this will enhance staff support and training and will foster evidence-based practice. The conceptualization of nursing language and its use by professionals helps to improve practice and the lack of a theoretical framework with a nurse perspective. It is necessary to establish a consensus between mental health nurses around the engagement' meaning in the programmes of assertive outreach teams. ABSTRACT: Introduction During last decade in Spain, nurses working in assertive outreach programmes have replaced the traditional institutional setting in favour of the patient's own environment. Engagement with patients requires a different skillset when the axis of the nurse-patient interaction is the patient's own environment. The engagement alone could be associated with the innate concept of patient's care and the helping relationship. However, in the individualized care models, the engagement seems to be an instrument with its own characteristics for the purpose of providing mental health care. Aim/Question To systematically identify and assess the empirical evidence on the relationships and engagement between patients with mental illness (schizophrenia, psychotic disorders, schizoaffective disorders, mood disorders and disorders of adult personality) and nursing mental health nurses. Method Systematic literature review based on PRISMA guidance. Results We identified and reviewed seven primary research studies. Following the analytic processes, three themes emerged: existence of different engagement levels, training needs and skills in the creation and consolidation of the engagement, and engagement as process. Discussion The engagement of nurse and patient is understood as a process that incorporates different stages. Whilst it is established, the engagement is subject to positive and negative influences. For the creation of the engagement and its maintenance specialized skills, knowledge and personal attributes (resilience, psychosocial skills, compressive knowledge of mental health illnesses, capacity to build effective relationships, adaptability and problem-solving) are necessary, but the main focus is on context where it develops, selected by the patient himself, for example, his home. Implications for Practice Administrators may have questions about appropriate hiring practices for assertive outreach teams since certain skills are necessary to obtain un engagement process, and staff training should be considered a key issue to provide specific skills for enhancing engagement and the therapeutic relationship. Conclusion The engagement must be understood as a long-term process. For the creation of the engagement and its maintenance, specialized skills, knowledge and personal attributes are necessary.

Quality appraisal of clinical guidelines for recurrent urinary tract infections using AGREE II: a systematic review.

INTRODUCTION AND HYPOTHESIS: Recommendations for preventing and diagnosing recurrent urinary tract infection (UTI) tend to vary between clinical practice guidelines (CPGs) because of low-quality scientific evidence, potentially leading to practice variation and suboptimal care. We assessed the quality of existing CPGs for recurrent UTI. METHODS: A systematic search was performed from January 2000 to June 2021 in PubMed and EMBASE for CPGs on recurrent UTI prevention or hospital diagnostics in Dutch, English, and Spanish. Each CPG was assessed by four appraisers in a multidisciplinary review team, using the Appraisal of Guidelines, Research, and Evaluation II (AGREE II) instrument. RESULTS: We identified and assessed eight CPGs published between 2013 and 2021. The scope and purpose (mean and standard deviation: 67.3 ± 21.8) and clarity of presentation (74.8 ± 17.6) domains scored highly. However, issues with methods, patient participation, conflict of interests, and facilitators and barriers were common and resulted in lower scores for the rigour of development (56.9 ± 25.9), applicability (19.6 ± 23.4), stakeholder involvement (50.4 ± 24.6), and editorial independence (62.1 ± 23.1) domains. Overall, two CPGs were recommended, three were recommended with modifications, and three were not recommended. CONCLUSIONS: Significant room for improvement exists in the quality of CPGs for recurrent UTI, with most displaying serious limitations in the stakeholder involvement, rigour of development, and applicability domains. These aspects must be improved to decrease diagnostic and therapeutic uncertainty. Developers could benefit from using checklists and following guidelines when developing de novo CPGs.

Vitamin D recommendations in clinical guidelines: A systematic review, quality evaluation and analysis of potential predictors.

BACKGROUND: Vitamin D has been widely promoted for bone health through supplementation and fortification of the general adult population. However, there is growing evidence that does not support these strategies. Our aim is to review the quality and recommendations on vitamin D nutritional and clinical practice guidelines and to explore predictive factors for their direction and strength. METHODS: We searched three databases and two guideline repositories from 2010 onwards. We performed a descriptive analysis, a quality appraisal using AGREE II scores (Appraisal of Guidelines Research and Evaluation) and a bivariate analysis evaluating the association between direction and strength of recommendations, AGREE II domains' scores and pre-specified characteristics. RESULTS: We included 34 guidelines, 44.1% recommended, 26.5% suggested and 29.4% did not recommend vitamin D supplementation. Guidelines that scored higher for "editorial independence" and "overall quality score" were less likely to recommend or suggest vitamin D supplementation (median 68.8 vs 35.4; P = .001 and 58.3 vs 37.5; P = .02). Guidance produced by government organisations and those that reported source of funding were associated with higher AGREE II scores. Unclear role of source of funding was associated with recommending or suggesting vitamin D supplementation (P = .034). Editorial independence was an independent predictor for recommending or suggesting vitamin D supplementation (OR 1.09; CI95% 1.02 to 1.16; P = .006). CONCLUSIONS: Policymakers, clinicians and patients should be aware that lower quality guidelines and those reporting conflicts of interest are more likely to promote vitamin D supplementation. Guideline organisations should improve the quality of their recommendations' development and the management of conflicts of interest. Users and editors should be aware of these findings when using and appraising guidelines.

Talking the same language on patient empowerment: Development and content validation of a taxonomy of self-management interventions for chronic conditions.

CONTEXT: The literature on self-management interventions (SMIs) is growing exponentially, but it is characterized by heterogeneous reporting that limits comparability across studies and interventions. Building an SMI taxonomy is the first step towards creating a common language for stakeholders to drive research in this area and promote patient self-management and empowerment. OBJECTIVE: To develop and validate the content of a comprehensive taxonomy of SMIs for long-term conditions that will help identify key characteristics and facilitate design, reporting and comparisons of SMIs. METHODS: We employed a mixed-methods approach incorporating a literature review, an iterative consultation process and mapping of key domains, concepts and elements to develop an initial SMI taxonomy that was subsequently reviewed in a two-round online Delphi survey with a purposive sample of international experts. RESULTS: The final SMI taxonomy has 132 components classified into four domains: intervention characteristics, expected patient/caregiver self-management behaviours, outcomes for measuring SMIs and target population characteristics. The two-round Delphi exercise involving 27 international experts demonstrated overall high agreement with the proposed items, with a mean score (on a scale of 1-9) per component of 8.0 (range 6.1-8.8) in round 1 and 8.1 (range 7.0-8.9) in round 2. CONCLUSIONS: The SMI taxonomy contributes to building a common framework for the patient self-management field and can help implement and improve patient empowerment and facilitate comparative effectiveness research of SMIs. Patient or public contribution. Patients' representatives contributed as experts in the Delphi process and as partners of the consortium.

Self-management interventions for adults living with Chronic Obstructive Pulmonary Disease (COPD): The development of a Core Outcome Set for COMPAR-EU project.

BACKGROUND: A large body of evidence suggests that self-management interventions (SMIs) may improve outcomes in chronic obstructive pulmonary disease (COPD). However, accurate comparisons of the relative effectiveness of SMIs are challenging, partly due to heterogeneity of outcomes across trials and uncertainty about the importance of these outcomes for patients. We aimed to develop a core set of patient-relevant outcomes (COS) for SMIs trials to enhance comparability of interventions and ensure person-centred care. METHODS: We undertook an innovative approach consisting of four interlinked stages: i) Development of an initial catalogue of outcomes from previous EU-funded projects and/or published studies, ii) Scoping review of reviews on patients and caregivers' perspectives to identify outcomes of interest, iii) Two-round Delphi online survey with patients and patient representatives to rate the importance of outcomes, and iv) Face-to-face consensus workshop with patients, patient representatives, health professionals and researchers to develop the COS. RESULTS: From an initial list of 79 potential outcomes, 16 were included in the COS plus one supplementary outcome relevant to all participants. These were related to patient and caregiver knowledge/competence, self-efficacy, patient activation, self-monitoring, adherence, smoking cessation, COPD symptoms, physical activity, sleep quality, caregiver quality of life, activities of daily living, coping with the disease, participation and decision-making, emergency room visits/admissions and cost effectiveness. CONCLUSION: The development of the COPD COS for the evaluation of SMIs will increase consistency in the measurement and reporting of outcomes across trials. It will also contribute to more personalized health care and more informed health decisions in clinical practice as patients' preferences regarding COPD outcomes are more systematically included.

Tailored PRISMA 2020 flow diagrams for living systematic reviews: a methodological survey and a proposal.

Background: While the PRISMA flow diagram is widely used for reporting standard systematic reviews (SRs), it was not designed for capturing the results of continual searches for studies in living systematic reviews (LSRs). The objectives of this study are (1) to assess how published LSRs report on the flow of studies through the different phases of the review for the different updates; (2) to propose an approach to reporting on that flow. Methods: For objective 1, we identified all LSRs published up to July 2020. We abstracted information regarding their general characteristics and how they reported on search results. For objective 2, we based our proposal for tailored PRISMA approaches on the findings from objective 1, as well as on our experience with conducting Cochrane LSRs. Results: We identified 108 living publications relating to 32 LSRs. Of the 108 publications, 7% were protocols, 24% were base versions (i.e., the first version), 62% were partial updates (i.e., does not include all typical sections of an SR), and 7% were full updates (i.e., includes all typical sections of an SR). We identified six ways to reporting the study flow: base separately, each update separately (38%); numbers not reported (32%); latest update separately, all previous versions combined (20%); base separately, all updates combined (7%); latest update version only (3%);  all versions combined (0%). We propose recording in detail the results of the searches to keep track of all identified records. For structuring the flow diagram, we propose using one of four approaches. Conclusion: We identified six ways for reporting the study flowthrough the different phases of the review for the different update versions. We propose to document in detail the study flow for the different search updates and select one of our four tailored PRISMA diagram approaches to present that study flow.

Minimal important difference estimates for patient-reported outcomes: A systematic survey.

OBJECTIVES: The objective of the study was to develop an inventory summarizing all anchor-based minimal important difference (MID) estimates for patient-reported outcome measures (PROMs) available in the medical literature. STUDY DESIGN AND SETTING: We searched MEDLINE, EMBASE, CINAHL, PsycINFO, and the Patient-Reported Outcome and Quality of Life Instruments Database internal library (January 1989-October 2018). We included primary studies empirically calculating an anchor-based MID estimate for any PROM in adults and adolescents. Pairs of reviewers independently screened and selected studies, extracted data, and evaluated the credibility of the MIDs. RESULTS: We identified 585 eligible studies, the majority conducted in Europe (n = 211) and North America (n = 179), reporting 5,324 MID estimates for 526 distinct PROMs. Investigators conducted their studies in the context of patients receiving surgical (n = 105, 18%), pharmacological (n = 85, 15%), rehabilitation (n = 65, 11%), or a combination of interventions (n = 194, 33%). Of all MID estimates, 59% (n = 3,131) used a global rating of change anchor. Major credibility limitations included weak correlation (n = 1,246, 23%) or no information regarding the correlation (n = 3,498, 66%) between the PROM and anchor and imprecision in the MID estimate (n = 2,513, 47%). CONCLUSION: A large number of MIDs for assisting in the interpretation of PROMs exist. The MID inventory will facilitate the use of MID estimates to inform the interpretation of the magnitude of treatment effects in clinical research and guideline development.

Developing trustworthy recommendations as part of an urgent response (1-2 weeks): a GRADE concept paper.

OBJECTIVES: The aim of this study is to propose an approach for developing trustworthy recommendations as part of urgent responses (1-2 week) in the clinical, public health, and health systems fields. STUDY DESIGN AND SETTING: We conducted a review of the literature, outlined a draft approach, refined the concept through iterative discussions, a workshop by the Grading of Recommendations Assessment, Development and Evaluation Rapid Guidelines project group, and obtained feedback from the larger Grading of Recommendations Assessment, Development and Evaluation working group. RESULTS: A request for developing recommendations within 2 week is the usual trigger for an urgent response. Although the approach builds on the general principles of trustworthy guideline development, we highlight the following steps: (1) assess the level of urgency; (2) assess feasibility; (3) set up the organizational logistics; (4) specify the question(s); (5) collect the information needed; (6) assess the adequacy of identified information; (7) develop the recommendations using one of the 4 potential approaches: adopt existing recommendations, adapt existing recommendations, develop new recommendations using existing adequate systematic review, or develop new recommendations using expert panel input; and (8) consider an updating plan. CONCLUSION: An urgent response for developing recommendations requires building a cohesive, skilled, and highly motivated multidisciplinary team with the necessary clinical, scientific, and methodological expertise; adapting to shifting needs; complying with the principles of transparency; and properly managing conflicts of interest.

Clinical manifestations, prevalence, risk factors, outcomes, transmission, diagnosis and treatment of COVID-19 in pregnancy and postpartum: a living systematic review protocol.

INTRODUCTION: Rapid, robust and continually updated evidence synthesis is required to inform management of COVID-19 in pregnant and postpartum women and to keep pace with the emerging evidence during the pandemic. METHODS AND ANALYSIS: We plan to undertake a living systematic review to assess the prevalence, clinical manifestations, risk factors, rates of maternal and perinatal complications, potential for mother-to-child transmission, accuracy of diagnostic tests and effectiveness of treatment for COVID-19 in pregnant and postpartum women (including after miscarriage or abortion). We will search Medline, Embase, WHO COVID-19 database, preprint servers, the China National Knowledge Infrastructure system and Wanfang databases from 1 December 2019. We will supplement our search with studies mapped by Cochrane Fertility and Gynaecology group, Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-Centre), COVID-19 study repositories, reference lists and social media blogs. The search will be updated every week and not be restricted by language. We will include observational cohort (≥10 participants) and randomised studies reporting on prevalence of COVID-19 in pregnant and postpartum women, the rates of clinical manifestations and outcomes, risk factors in pregnant and postpartum women alone or in comparison with non-pregnant women with COVID-19 or pregnant women without COVID-19 and studies on tests and treatments for COVID-19. We will additionally include case reports and series with evidence on mother-to-child transmission of SARS-CoV-2 in utero, intrapartum or postpartum. We will appraise the quality of the included studies using appropriate tools to assess the risk of bias. At least two independent reviewers will undertake study selection, quality assessment and data extraction every 2 weeks. We will synthesise the findings using quantitative random effects meta-analysis and report OR or proportions with 95% CIs and prediction intervals. Case reports and series will be reported as qualitative narrative synthesis. Heterogeneity will be reported as I2 and τ2 statistics. ETHICS AND DISSEMINATION: Ethical approval is not required as this is a synthesis of primary data. Regular updates of the results will be published on a dedicated website (https://www.birmingham.ac.uk/research/who-collaborating-centre/pregcov/index.aspx) and disseminated through publications, social media and webinars. PROSPERO REGISTRATION NUMBER: CRD42020178076.

Feeding modifications and additional primary caregiver support for infants exposed to Zika virus or diagnosed with congenital Zika syndrome: a rapid review of the evidence.

OBJECTIVE: Infants exposed to Zika virus (ZIKV) or diagnosed with congenital Zika syndrome (CZVS) may present dysphagia, regurgitation and other feeding difficulties. They may require special feeding practices to minimise the risk of mortality, morbidity and developmental problems. Improving knowledge, skills and behaviours of caregivers may preserve health, maximise development and promote quality of life among affected infants. We reviewed intervention studies of modified feeding practices and additional primary caregiver support to improve outcomes among infants 0 to 12 months of age exposed to ZIKV or diagnosed with CZVS. METHODS: Rapid review and meta-analysis. We searched PubMed/MEDLINE and contacted experts. The search is current to 18 July 2020. We planned a meta-analysis using fixed-effect models; if unfeasible, we intended to summarise studies narratively. We planned to assess risk of bias of included studies and quality of evidence using Cochrane guidance. RESULTS: We identified 42 records for title and abstract screening; 14 were eligible for full-text assessment. Among these, no intervention studies were found. Eight observational studies reported on the nutritional status, feeding practices and outcomes among infants affected by ZIKV or diagnosed with CZVS. They are presented and discussed to provide a basis for future research. CONCLUSIONS: While no intervention studies were found, evidence from eight observational studies highlights the need for early nutrition interventions and caregiver support among infants affected by ZIKV or diagnosed with CZSV. More research is needed to assess whether modifications of feeding practices and provision of additional primary caregiver support will impact outcomes of interest.

OBJECTIF: Les nourrissons exposés au virus Zika (VZIK) ou diagnostiqués avec le syndrome congénital Zika (SCZ) peuvent présenter une dysphagie, des régurgitations et d'autres difficultés d'alimentation. Ils peuvent nécessiter des pratiques alimentaires spéciales pour minimiser le risque de mortalité, de morbidité et de problèmes de développement. L'amélioration des connaissances, des compétences et des comportements des soignants peut préserver la santé, maximiser le développement et promouvoir la qualité de vie des nourrissons affectés. Nous avons examiné les études d'intervention sur les pratiques d'alimentation modifiées et le soutien additionnel aux principaux soignants pour améliorer les résultats chez les nourrissons de 0 à 12 mois exposés au VZIK ou diagnostiqués avec le SCZ. MÉTHODES: Revue rapide et méta-analyse. Nous avons effectué des recherches dans PubMed/MEDLINE et contacté des experts. La recherche a été mise à jour au 18 juillet 2020. Nous avons prévu une méta-analyse utilisant des modèles à effets fixes; si cela n'était pas réalisable, nous avions l'intention de résumer les études de manière narrative. Nous avons prévu d'évaluer le risque de biais des études incluses et la qualité des données en utilisant les directives Cochrane. RÉSULTATS: Nous avons identifié 42 reports pour la recherche des titres et des résumés; 14 étaient éligibles pour une évaluation en texte intégral. Parmi ceux-ci, aucune étude d'intervention n'a été trouvée. Huit études observationnelles ont rapporté sur l'état nutritionnel, les pratiques d'alimentation et les résultats chez les nourrissons atteints du VZIK ou diagnostiqués avec le SCZ. Elles sont présentées et discutées pour fournir une base pour les futures recherches. CONCLUSIONS: Bien qu'aucune étude d'intervention n'ait été trouvée, les données de huit études observationnelles mettent en évidence la nécessité d'interventions nutritionnelles précoces et de soutien des soignants des nourrissons atteints de VZIK ou diagnostiqués avec le SCZ. Des recherches supplémentaires sont nécessaires pour évaluer si les modifications des pratiques d'alimentation et la fourniture d'un soutien additionnel aux principaux soignants auront un impact sur les résultats d'intérêt.

Drug treatments for covid-19: living systematic review and network meta-analysis

OBJECTIVE: To compare the effects of treatments for coronavirus disease 2019 (covid-19). DESIGN: Living systematic review and network meta-analysis. DATA SOURCES: WHO covid-19 database, a comprehensive multilingual source of global covid-19 literature, up to 3 December 2021 and six additional Chinese databases up to 20 February 2021. Studies identified as of 1 December 2021 were included in the analysis. STUDY SELECTION: Randomised clinical trials in which people with suspected, probable, or confirmed covid-19 were randomised to drug treatment or to standard care or placebo. Pairs of reviewers independently screened potentially eligible articles. METHODS: After duplicate data abstraction, a bayesian network meta-analysis was conducted. Risk of bias of the included studies was assessed using a modification of the Cochrane risk of bias 2.0 tool, and the certainty of the evidence using the grading of recommendations assessment, development, and evaluation (GRADE) approach. For each outcome, interventions were classified in groups from the most to the least beneficial or harmful following GRADE guidance. RESULTS: 463 trials enrolling 166 581 patients were included; 267 (57.7%) trials and 89 814 (53.9%) patients are new from the previous iteration; 265 (57.2%) trials evaluating treatments with at least 100 patients or 20 events met the threshold for inclusion in the analyses. Compared with standard care, three drugs reduced mortality in patients with mostly severe disease with at least moderate certainty: systemic corticosteroids (risk difference 23 fewer per 1000 patients, 95% credible interval 40 fewer to 7 fewer, moderate certainty), interleukin-6 receptor antagonists when given with corticosteroids (23 fewer per 1000, 36 fewer to 7 fewer, moderate certainty), and Janus kinase inhibitors (44 fewer per 1000, 64 fewer to 20 fewer, high certainty). Compared with standard care, two drugs probably reduce hospital admission in patients with non-severe disease: nirmatrelvir/ritonavir (36 fewer per 1000, 41 fewer to 26 fewer, moderate certainty) and molnupiravir (19 fewer per 1000, 29 fewer to 5 fewer, moderate certainty). Remdesivir may reduce hospital admission (29 fewer per 1000, 40 fewer to 6 fewer, low certainty). Only molnupiravir had at least moderate quality evidence of a reduction in time to symptom resolution (3.3 days fewer, 4.8 fewer to 1.6 fewer, moderate certainty); several others showed a possible benefit. Several drugs may increase the risk of adverse effects leading to drug discontinuation; hydroxychloroquine probably increases the risk of mechanical ventilation (moderate certainty). CONCLUSION: Corticosteroids, interleukin-6 receptor antagonists, and Janus kinase inhibitors probably reduce mortality and confer other important benefits in patients with severe covid-19. Molnupiravir and nirmatrelvir/ritonavir probably reduce admission to hospital in patients with non-severe covid-19. SYSTEMATIC REVIEW REGISTRATION: This review was not registered. The protocol is publicly available in the supplementary material. READERS' NOTE: This article is a living systematic review that will be updated to reflect emerging evidence. Updates may occur for up to two years from the date of original publication. This is the fifth version of the original article published on 30 July 2020 (BMJ 2020;370:m2980), and previous versions can be found as data supplements. When citing this paper please consider adding the version number and date of access for clarity.

The UpPriority tool was developed to guide the prioritization of clinical guideline questions for updating.

OBJECTIVE: The objective of the study is to develop a pragmatic tool to prioritize clinical guideline (CG) questions for updating, the UpPriority tool. STUDY DESIGN AND SETTING: The development of this tool consisted of the following: (1) establishment of the working group, (2) generation of the initial version, (3) optimization of the tool (including an initial feasibility test, semistructured interviews, Delphi consensus survey, second feasibility test, external review, and pilot test), and (4) approval of the final version. RESULTS: A total of 87 participants including methodologists, clinicians, and other relevant stakeholders contributed to the development of the UpPriority tool. The tool consists of six items: (1) impact of outdated recommendations on safety, (2) availability of new relevant evidence, (3) context relevance of the clinical question, (4) methodological applicability of the clinical question, (5) user's interest, and (6) impact on access to health care. The UpPriority tool includes detailed guidance for using the tool and rating each item (using a 7-point Likert scale), for calculating and ranking the questions, and for summarizing results. CONCLUSION: The UpPriority tool could be useful for standardizing prioritization processes when updating CGs and for fostering more efficient use of resources in the CG field.

Quality of reporting for randomised clinical trials published in Latin American and Spanish journals: A protocol for a systematic survey of three clinical specialities.

INTRODUCTION: Quality of reporting refers to how published articles communicate how the research was done and what was found. Gaps and imprecisions of reporting hamper the assessment of the methodological quality and internal and external validity. The CONsolidated Standards of Reporting Trials (CONSORT) are a set of evidence-based recommendations of the minimum elements to be included in the reporting of randomised controlled trials (RCTs) to ensure a complete and transparent account of what was done, how it was done and what was found. Few studies have been conducted on the impact of CONSORT on RCTs published in Latin American and Spanish journals. We aim to assess the reporting quality of RCTs of three clinical specialities published in Spanish and Latin American journals, as well as to assess changes over time and associations of quality with journal and country indicators. METHODS AND ANALYSIS: We will conduct a systematic survey of all RCTs published in Spanish-language journals in three clinical fields (dentistry, neurology and geriatrics) from 1990 to 2018. We will include RCTs from previous work that has identified all RCTs on these medical fields published in Spain and Latin America. We will update this work via handsearching of relevant journals. Assessment of quality of reporting will be conducted independently and in duplicate using the CONSORT 2010 Statement. We will also extract journal and country indicators. We will conduct descriptive statistics and secondary analyses considering the year, country, and journal of publication, among others. ETHICS AND DISSEMINATION: The Universidad de Santiago de Chile's ethics committee approved the protocol. We will disseminate the results of this work in peer-reviewed scientific journals and conference proceedings. We expect to raise awareness among researchers, journal editors and funders on the importance of training in reporting guidelines and using them from the inception of RCT protocols.