General practitioners' risk literacy and real-world prescribing of potentially hazardous drugs: a cross-sectional study.

BACKGROUND: Overuse of medical care is a pervasive problem. Studies using hypothetical scenarios suggest that physicians' risk literacy influences medical decisions; real-world correlations, however, are lacking. We sought to determine the association between physicians' risk literacy and their real-world prescriptions of potentially hazardous drugs, accounting for conflicts of interest and perceptions of benefit-harm ratios in low-value prescribing scenarios. SETTING AND SAMPLE: Cross-sectional study-conducted online between June and October 2023 via field panels of Sermo (Hamburg, Germany)-with a convenience sample of 304 English general practitioners (GPs). METHODS: GPs' survey responses on their treatment-related risk literacy, conflicts of interest and perceptions of the benefit-harm ratio in low-value prescribing scenarios were matched to their UK National Health Service records of prescribing volumes for antibiotics, opioids, gabapentin and benzodiazepines and analysed for differences. RESULTS: 204 GPs (67.1%) worked in practices with ≥6 practising GPs and 226 (76.0%) reported 10-39 years of experience. Compared with GPs demonstrating low risk literacy, GPs with high literacy prescribed fewer opioids (mean (M): 60.60 vs 43.88 prescribed volumes/1000 patients/6 months, p=0.016), less gabapentin (M: 23.84 vs 18.34 prescribed volumes/1000 patients/6 months, p=0.023), and fewer benzodiazepines (M: 17.23 vs 13.58 prescribed volumes/1000 patients/6 months, p=0.037), but comparable volumes of antibiotics (M: 48.84 vs 40.61 prescribed volumes/1000 patients/6 months, p=0.076). High-risk literacy was associated with lower conflicts of interest (ϕ = 0.12, p=0.031) and higher perception of harms outweighing benefits in low-value prescribing scenarios (p=0.007). Conflicts of interest and benefit-harm perceptions were not independently associated with prescribing behaviour (all ps >0.05). CONCLUSIONS AND RELEVANCE: The observed association between GPs with higher risk literacy and the prescription of fewer hazardous drugs suggests the importance of risk literacy in enhancing patient safety and quality of care.

Development of a patient decision aid for children and adolescents following anterior cruciate ligament rupture: an international mixed-methods study.

AIM: To develop and user test an evidence-based patient decision aid for children and adolescents who are considering anterior cruciate ligament (ACL) reconstruction. DESIGN: Mixed-methods study describing the development of a patient decision aid. SETTING: A draft decision aid was developed by a multidisciplinary steering group (including various types of health professionals and researchers, and consumers) informed by the best available evidence and existing patient decision aids. PARTICIPANTS: People who ruptured their ACL when they were under 18 years old (ie, adolescents), their parents, and health professionals who manage these patients. Participants were recruited through social media and the network outreach of the steering group. PRIMARY AND SECONDARY OUTCOMES: Semistructured interviews and questionnaires were used to gather feedback on the decision aid. The feedback was used to refine the decision aid and assess acceptability. An iterative cycle of interviews, refining the aid according to feedback and further interviews, was used. Interviews were analysed using reflexive thematic analysis. RESULTS: We conducted 32 interviews; 16 health professionals (12 physiotherapists, 4 orthopaedic surgeons) and 16 people who ruptured their ACL when they were under 18 years old (7 were adolescents and 9 were adults at the time of the interview). Parents participated in 8 interviews. Most health professionals, patients and parents rated the aid's acceptability as good-to-excellent. Health professionals and patients agreed on most aspects of the decision aid, but some health professionals had differing views on non-surgical management, risk of harms, treatment protocols and evidence on benefits and harms. CONCLUSION: Our patient decision aid is an acceptable tool to help children and adolescents choose an appropriate management option following ACL rupture with their parents and health professionals. A clinical trial evaluating the potential benefit of this tool for children and adolescents considering ACL reconstruction is warranted.

Clinical trials and their impact on policy during COVID-19: a review.

Background: Of over 8,000 recorded randomised trials addressing COVID-19, around 80% were of treatments, and 17% have reported results. Approximately 1% were adaptive or platform trials, with 25 having results available, across 29 journal articles and 10 preprint articles. Methods: We conducted an extensive literature review to address four questions about COVID-19 trials, particularly the role and impact of platform/adaptive trials and lessons learned. Results: The key findings were: Q1. Social value in conducting trials and uptake into policy? COVID-19 drug treatments varied substantially and changed considerably, with drugs found effective in definitive clinical trials replacing unproven drugs. Dexamethasone has likely saved ½-2 million lives, and was cost effective across a range of countries and populations, whereas the cost effectiveness of remdesivir is uncertain. Published economic and health system impacts of COVID-19 treatments were infrequent. Q2. Issues with adaptive trial designs. Of the 77 platform trials registered, 6 major platform trials, with approximately 50 treatment arms, recruited ~135,000 participants with funding over $100 million. Q3. Models of good practice. Streamlined set-up processes such as flexible and fast-track funding, ethics, and governance approvals are vital. To facilitate recruitment, simple and streamlined research processes, and pre-existing research networks to coordinate trial planning, design, conduct and practice change are crucial to success. Q4. Potential conflicts to avoid? When treating patients through trials, balancing individual and collective rights and allocating scarce resources between healthcare and research are challenging. Tensions occur between commercial and non-commercial sectors, and academic and public health interests, such as publication and funding driven indicators and the public good. Conclusion: There is a need to (i) reduce small, repetitive, single centre trials, (ii) increase coordination to ensure robust research conducted for treatments, and (iii) a wider adoption of adaptive/platform trial designs to respond to fast-evolving evidence landscape.

Diagnostic performance of clinical prediction rules to detect group A beta-haemolytic streptococci in people with acute pharyngitis: a systematic review.

OBJECTIVE: To assess and compare the diagnostic performance of Clinical Prediction Rules (CPRs) developed to detect group A Beta-haemolytic streptococci in people with acute pharyngitis (or sore throat). STUDY DESIGN: A systematic review. METHODS: We searched PubMed, Embase and Web of Science (inception-September 2022) for studies deriving and/or validating CPRs comprised of ≥2 predictors from an individual's history or physical examination. Two authors independently screened articles, extracted data and assessed risk of bias in included studies. A meta-analysis was not possible due to heterogeneity. Instead we compared the performance of CPRs when they were validated in the same study population (head-to-head comparisons). We used a modified grading of recommendations, assessment, development, and evaluations (GRADE) approach to assess certainty of the evidence. RESULTS: We included 63 studies, all judged at high risk of bias. Of 24 derived CPRs, 7 were externally validated (in 46 external validations). Five validation studies provided data for head-to-head comparison of four pairs of CPRs. Very low certainty evidence favoured the Centor CPR over the McIsaac (2 studies) and FeverPain CPRs (1 study) and found the Centor CPR was equivalent to the Walsh CPR (1 study). The AbuReesh and Steinhoff 2005 CPRs had a similar poor discriminative ability (1 study). Within and between study comparisons suggested the performance of the Centor CPR may be better in adults (>18 years). CONCLUSION: Very low certainty evidence suggests a better performance of the Centor CPR. When deciding about antibiotic prescribing for pharyngitis patients, involving patients in a shared decision making discussion about the likely benefits and harms, including antibiotic resistance, is recommended. Further research of higher rigour, which compares CPRs across multiple settings, is needed.

Development of the Reporting Infographics and Visual Abstracts of Comparative studies (RIVA-C) checklist and guide.

People often use infographics (also called visual or graphical abstracts) as a substitute for reading the full text of an article. This is a concern because most infographics do not present sufficient information to interpret the research appropriately and guide wise health decisions. The Reporting Infographics and Visual Abstracts of Comparative studies (RIVA-C) checklist and guide aims to improve the completeness with which research findings of comparative studies are communicated and avoid research findings being misinterpreted if readers do not refer to the full text. The primary audience for the RIVA-C checklist and guide is developers of infographics that summarise comparative studies of health and medical interventions. The need for the RIVA-C checklist and guide was identified by a survey of how people use infographics. Possible checklist items were informed by a systematic review of how infographics report research. We then conducted a two-round, modified Delphi survey of 92 infographic developers/designers, researchers, health professionals and other key stakeholders. The final checklist includes 10 items. Accompanying explanation and both text and graphical examples linked to the items were developed and pilot tested over a 6-month period. The RIVA-C checklist and guide was designed to facilitate the creation of clear, transparent and sufficiently detailed infographics which summarise comparative studies of health and medical interventions. Accurate infographics can ensure research findings are communicated appropriately and not misinterpreted. By capturing the perspectives of a wide range of end users (eg, authors, informatics editors, journal editors, consumers), we are hopeful of rapid endorsement and implementation of RIVA-C.

Attitudes, beliefs, behaviours and perspectives on barriers and enablers of Australian general practitioners towards non-drug interventions: a national survey.

BACKGROUND: Many guidelines recommend non-drug interventions (NDIs) for managing common conditions in primary care. However, compared with drug interventions, NDIs are less widely known, promoted and used. We aim to (1) examine general practitioners' (GPs') knowledge, attitudes and practices for NDIs, including their use of the Royal Australian College of General Practitioners (RACGP) Handbook of Non-Drug Interventions (HANDI), and (2) identify factors influencing their use of NDIs and HANDI. METHODS: We conducted a web-based cross-sectional survey of practicing GP members in Australia during October-November 2022. The survey contained five sections: characteristics of GP; knowledge and use of NDIs; attitudes towards NDIs; barriers and enablers to using HANDI; and suggestions of NDIs and ideas to improve the uptake of NDIs in primary care. RESULTS: Of the 366 GPs who completed the survey, 242 (66%) were female, and 248 (74%) were ≥45 years old. One in three GPs reported that they regularly ('always') recommend NDIs to their patients when appropriate (34%), whereas one-third of GPs were unaware of HANDI (39%). GPs identified several factors that improve the uptake of HANDI, including 'access and integration of HANDI in clinical practice', 'content and support to use in practice' and 'awareness and training'. CONCLUSIONS: While many GPs are aware of the effectiveness of NDIs and often endorse their use, obstacles still prevent widespread adoption in primary care. The results of this survey can serve as a foundation for developing implementation strategies to improve the uptake of effective evidence-based NDIs in primary care.

Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation.

OBJECTIVES: Clinical study reports (CSRs) are highly detailed documents that play a pivotal role in medicine approval processes. Though not historically publicly available, in recent years, major entities including the European Medicines Agency (EMA), Health Canada, and the US Food and Drug Administration (FDA) have highlighted the importance of CSR accessibility. The primary objective herein was to determine the proportion of CSRs that support medicine approvals available for public download as well as the proportion eligible for independent researcher request via the study sponsor. STUDY DESIGN AND SETTING: This cross-sectional study examined the accessibility of CSRs from industry-sponsored clinical trials whose results were reported in the FDA-authorized drug labels of the top 30 highest-revenue medicines of 2021. We determined (1) whether the CSRs were available for download from a public repository, and (2) whether the CSRs were eligible for request by independent researchers based on trial sponsors' data sharing policies. RESULTS: There were 316 industry-sponsored clinical trials with results presented in the FDA-authorized drug labels of the 30 sampled medicines. Of these trials, CSRs were available for public download from 70 (22%), with 37 available at EMA and 40 at Health Canada repositories. While pharmaceutical company platforms offered no direct downloads of CSRs, sponsors confirmed that CSRs from 183 (58%) of the 316 clinical trials were eligible for independent researcher request via the submission of a research proposal. Overall, 218 (69%) of the sampled clinical trials had CSRs available for public download and/or were eligible for request from the trial sponsor. CONCLUSION: CSRs were available from 69% of the clinical trials supporting regulatory approval of the 30 medicines sampled. However, only 22% of the CSRs were directly downloadable from regulatory agencies, the remaining required a formal application process to request access to the CSR from the study sponsor.

In Search of a Gold Standard Tool for Assessing Knowledge of Stroke: A Systematic Review.

BACKGROUND: Knowledge of stroke is essential to empower people to reduce their risk of these events. However, valid tools are required for accurate and reliable measurement of stroke knowledge. We aimed to systematically review contemporary stroke knowledge assessment tools and appraise their content validity, feasibility, and measurement properties. METHODS: The protocol was registered in PROSPERO (CRD42023403566). Electronic databases (MEDLINE, PsycInfo, CINAHL, Embase, Scopus, Web of Science) were searched to identify published articles (1 January 2015-1 March 2023), in which stroke knowledge was assessed using a validated tool. Two reviewers independently screened titles and abstracts prior to undertaking full-text review. COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methods guided the appraisal of content validity (relevance, comprehensiveness, comprehensibility), feasibility, and measurement properties. RESULTS: After removing duplicates, the titles and abstracts of 718 articles were screened; 323 reviewed in full; with 42 included (N = 23 unique stroke knowledge tools). For content validity, all tools were relevant, two were comprehensive, and seven were comprehensible. Validation metrics were reported for internal consistency (n = 20 tools), construct validity (n = 17 tools), cross-cultural validity (n = 15 tools), responsiveness (n = 9 tools), reliability (n = 7 tools), structural validity (n = 3 tools), and measurement error (n = 1 tool). The Stroke Knowledge Test met all content validity criteria, with validation data for six measurement properties (n = 3 rated "Sufficient"). CONCLUSION: Assessment of stroke knowledge is not standardised and many tools lacked validated content or measurement properties. The Stroke Knowledge Test was the most comprehensive but requires updating and further validation for endorsement as a gold standard.

A 10-year update to the principles for clinical trial data sharing by pharmaceutical companies: perspectives based on a decade of literature and policies.

Data sharing is essential for promoting scientific discoveries and informed decision-making in clinical practice. In 2013, PhRMA/EFPIA recognised the importance of data sharing and supported initiatives to enhance clinical trial data transparency and promote scientific advancements. However, despite these commitments, recent investigations indicate significant scope for improvements in data sharing by the pharmaceutical industry. Drawing on a decade of literature and policy developments, this article presents perspectives from a multidisciplinary team of researchers, clinicians, and consumers. The focus is on policy and process updates to the PhRMA/EFPIA 2013 data sharing commitments, aiming to enhance the sharing and accessibility of participant-level data, clinical study reports, protocols, statistical analysis plans, lay summaries, and result publications from pharmaceutical industry-sponsored trials. The proposed updates provide clear recommendations regarding which data should be shared, when it should be shared, and under what conditions. The suggested improvements aim to develop a data sharing ecosystem that supports science and patient-centred care. Good data sharing principles require resources, time, and commitment. Notwithstanding these challenges, enhancing data sharing is necessary for efficient resource utilization, increased scientific collaboration, and better decision-making for patients and healthcare professionals.

Developing a patient decision aid for Achilles tendon rupture management: a mixed-methods study.

OBJECTIVE: To develop and user-test a patient decision aid portraying the benefits and harms of non-surgical management and surgery for Achilles tendon ruptures. DESIGN: Mixed methods. SETTING: A draft decision aid was developed using guidance from a multidisciplinary steering group and existing patient decision aids. Participants were recruited through social media. PARTICIPANTS: People who have previously sustained an Achilles tendon rupture and health professionals who manage these patients. PRIMARY AND SECONDARY OUTCOMES: Semi-structured interviews and questionnaires were used to gather feedback on the decision aid from health professionals and patients who had previously suffered an Achilles tendon rupture. The feedback was used to redraft the decision aid and assess acceptability. An iterative cycle of interviews, redrafting according to feedback and further interviews was used. Interviews were analysed using reflexive thematic analysis. Questionnaire data were analysed descriptively. RESULTS: We interviewed 18 health professionals (13 physiotherapists, 3 orthopaedic surgeons, 1 chiropractor, 1 sports medicine physician) and 15 patients who had suffered an Achilles tendon rupture (median time since rupture was 12 months). Most health professionals and patients rated the aid's acceptability as good-excellent. Interviews showcased agreement among health professionals and patients on most aspects of the decision aid: introduction, treatment options, comparing benefits and harms, questions to ask health professionals and formatting. However, health professionals had differing views on details about Achilles tendon retraction distance, factors that modify the risk of harms, treatment protocols and evidence on benefits and harms. CONCLUSION: Our patient decision aid is an acceptable tool to both patients and health professionals, and our study highlights the views of key stakeholders on important information to consider when developing a patient decision aid for Achilles tendon rupture management. A randomised controlled trial evaluating the impact of this tool on the decision-making of people considering Achilles tendon surgery is warranted.

Effect of different visual presentations on the public's comprehension of prognostic information using acute and chronic condition scenarios: two online randomised controlled trials.

OBJECTIVES: To assess the effectiveness of bar graph, pictograph and line graph compared with text-only, and to each other, for communicating prognosis to the public. DESIGN: Two online four-arm parallel-group randomised controlled trials. Statistical significance was set at p<0.016 to allow for three-primary comparisons. PARTICIPANTS AND SETTING: Two Australian samples were recruited from members registered at Dynata online survey company. In trial A: 470 participants were randomised to one of the four arms, 417 were included in the analysis. In trial B: 499 were randomised and 433 were analysed. INTERVENTIONS: In each trial four visual presentations were tested: bar graph, pictograph, line graph and text-only. Trial A communicated prognostic information about an acute condition (acute otitis media) and trial B about a chronic condition (lateral epicondylitis). Both conditions are typically managed in primary care where 'wait and see' is a legitimate option. MAIN OUTCOME: Comprehension of information (scored 0-6). SECONDARY OUTCOMES: Decision intention, presentation satisfaction and preferences. RESULTS: In both trials, the mean comprehension score was 3.7 for the text-only group. None of the visual presentations were superior to text-only. In trial A, the adjusted mean difference (MD) compared with text-only was: 0.19 (95% CI -0.16 to 0.55) for bar graph, 0.4 (0.04 to 0.76) for pictograph and 0.06 (-0.32 to 0.44) for line graph. In trial B, the adjusted MD was: 0.1 (-0.27 to 0.47) for bar graph), 0.38 (0.01 to 0.74) for pictograph and 0.1 (-0.27 to 0.48) for line graph. Pairwise comparisons between the three graphs showed all were clinically equivalent (95% CIs between -1.0 and 1.0). In both trials, bar graph was the most preferred presentation (chosen by 32.9% of trial A participants and 35.6% in trial B). CONCLUSIONS: Any of the four visual presentations tested may be suitable to use when discussing quantitative prognostic information. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12621001305819).

Preventing depression in aphasia: A cluster randomized control trial of the Aphasia Action Success Knowledge (ASK) program.

BACKGROUND: Stroke patients with aphasia and their caregivers have higher incidence of depression than those without aphasia. AIMS: The objective of the study is to determine whether a tailored intervention program (Action Success Knowledge; ASK) led to better mood and quality of life (QoL) outcomes than an attention control with a 12-month end point at cluster and individual participant level. METHODS: A multi-site, pragmatic, two-level single-blind cluster randomized controlled trial compared ASK to an attention control (secondary stroke prevention program). Ten metropolitan and 10 non-metropolitan health regions were randomized. People with aphasia and their family members were recruited within 6 months post-stroke who scored ⩽12 on the Stroke Aphasic Depression Questionnaire Hospital Version-10 at screening. Each arm received manualized intervention over 6-8 weeks followed by monthly telephone calls. Blinded assessments of QoL and depression were taken at 12 months post-onset. RESULTS: Twenty clusters (health regions) were randomized. Trained speech pathologists screened 1744 people with aphasia and 373 participants consented to intervention (n = 231 people with aphasia and 142 family members). The attrition rate after consent was 26% with 86 and 85 participants with aphasia in the ASK arm and attention control arm, respectively, receiving intervention. Of those 171 who did receive treatment, only 41 met the prescribed minimum dose. Multilevel mixed effects modeling under the intention-to-treat protocol showed a significant difference on the Stroke and Aphasia Depression Questionnaire-21 (SADQ-21, N = 122, 17 clusters) in favor of the attention control (ß = -2.74, 95% confidence interval (CI) = -4.76 to -0.73, p = 0.008). Individual data analysis using a minimal detectable change score for the SADQ-21 showed the difference was not meaningful. CONCLUSION: ASK showed no benefit over attention control in improving mood and preventing depression in people with aphasia or their family members.

Exploring general practitioners' perception of the value of natural history information and their awareness and use of guidelines' resources to support antibiotic prescribing for self-limiting infections: a qualitative study in Australian general practice.

BACKGROUND: The newest version of the Therapeutic Guidelines' antibiotic chapter introduced patient- and clinician-facing resources to support decision-making about antibiotic use for self-limiting infections. It is unclear whether general practitioners (GPs) are aware of and use these resources, including the natural history information they contain. We explored GPs' perceptions of the value and their use of natural history information, and their use of the Therapeutic Guidelines' resources (summary table, discussion boxes, decision aids) to support antibiotic decision-making. METHODS: Semi-structured interviews with 21 Australian GPs were conducted. Interviews were recorded, transcribed and thematically analysed by two independent researchers. RESULTS: Four themes emerged: (1) GPs perceive natural history information as valuable in consultations for self-limiting conditions and use it for a range of purposes, but desire specific information for infectious and non-infectious conditions; (2) GPs' reasons for using patient-facing resources were manifold, including managing patients' expectations for antibiotics, legitimising the decision not to provide antibiotics and as a prescription substitute; (3) the guidelines are a useful and important educational resource, but typically not consulted at the time of deciding whether to prescribe antibiotics; and (4) experience and attitude towards shared decision-making and looking up information during consultations influenced whether GPs involved patients in decision-making and used a decision aid. CONCLUSIONS: GPs perceived natural history information to be valuable in discussions about antibiotic use for self-limiting conditions. Patient and clinician resources were generally perceived as useful, although reasons for use varied, and a few barriers to use were reported.

Nondrug interventions for reducing SARS-CoV-2 transmission are frequently incompletely reported.

OBJECTIVES: To investigate the completeness of reporting of behavioral, environmental, social and system interventions (BESSI) for reducing the transmission of SARS-CoV-2 evaluated in randomized trials, to obtain missing intervention details and to document the interventions assessed. STUDY DESIGN AND SETTING: We assessed completeness of reporting in randomized trials of BESSI using the Template for Intervention Description and Replication (TIDieR) checklist. Investigators were contacted to provide missing intervention details and if provided, intervention descriptions were reassessed and documented according to the TIDieR items. RESULTS: Forty-five trials (planned or complete) describing 21 educational interventions, 15 protective measures, and nine social distancing interventions were included. In 30 trials with a protocol or study report, 30% (9/30) of interventions were completely described; this increased to 53% (16/30) after contacting 24 trial investigators (11 responded). Across all interventions, intervention provider training (35%) was the most frequently incompletely described checklist item, followed by the 'when and how much' intervention item. CONCLUSION: Incomplete reporting of BESSI is a substantial problem with essential information necessary for implementation of interventions and for building on existing knowledge frequently missing and unable to be obtained. Such reporting is an avoidable source of research waste.

Incomplete reporting of complex interventions: a call to action for journal editors to review their submission guidelines.

Reporting of intervention research has been inadequate for many years. The development and promotion of freely available checklists aims to address this problem by providing researchers with a list of items that require reporting to enable study interpretation and replication. In this commentary, we present evidence from a recent systematic review of 51 randomised controlled trials published 2015-2020 that inadequate intervention reporting remains a widespread issue and that checklists are not being used to describe all intervention components. In 2022, we assessed the submission guidelines of 33 journals that published articles included in our review and found that just one at the time encouraged the use of reporting checklists for all intervention components. To drive progress, we contacted the editors of the other 32 journals and requested that they update their submission guidelines in response. We conclude by highlighting the waste associated with current practices and encourage journals from all fields to urgently review their submission guidelines. Only through collective action can we build an evidence base that is fit for purpose.

Physical interventions to interrupt or reduce the spread of respiratory viruses.

BACKGROUND: Viral epidemics or pandemics of acute respiratory infections (ARIs) pose a global threat. Examples are influenza (H1N1) caused by the H1N1pdm09 virus in 2009, severe acute respiratory syndrome (SARS) in 2003, and coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in 2019. Antiviral drugs and vaccines may be insufficient to prevent their spread. This is an update of a Cochrane Review last published in 2020. We include results from studies from the current COVID-19 pandemic. OBJECTIVES: To assess the effectiveness of physical interventions to interrupt or reduce the spread of acute respiratory viruses. SEARCH METHODS: We searched CENTRAL, PubMed, Embase, CINAHL, and two trials registers in October 2022, with backwards and forwards citation analysis on the new studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and cluster-RCTs investigating physical interventions (screening at entry ports, isolation, quarantine, physical distancing, personal protection, hand hygiene, face masks, glasses, and gargling) to prevent respiratory virus transmission.  DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. MAIN RESULTS: We included 11 new RCTs and cluster-RCTs (610,872 participants) in this update, bringing the total number of RCTs to 78. Six of the new trials were conducted during the COVID-19 pandemic; two from Mexico, and one each from Denmark, Bangladesh, England, and Norway. We identified four ongoing studies, of which one is completed, but unreported, evaluating masks concurrent with the COVID-19 pandemic. Many studies were conducted during non-epidemic influenza periods. Several were conducted during the 2009 H1N1 influenza pandemic, and others in epidemic influenza seasons up to 2016. Therefore, many studies were conducted in the context of lower respiratory viral circulation and transmission compared to COVID-19. The included studies were conducted in heterogeneous settings, ranging from suburban schools to hospital wards in high-income countries; crowded inner city settings in low-income countries; and an immigrant neighbourhood in a high-income country. Adherence with interventions was low in many studies. The risk of bias for the RCTs and cluster-RCTs was mostly high or unclear. Medical/surgical masks compared to no masks We included 12 trials (10 cluster-RCTs) comparing medical/surgical masks versus no masks to prevent the spread of viral respiratory illness (two trials with healthcare workers and 10 in the community). Wearing masks in the community probably makes little or no difference to the outcome of influenza-like illness (ILI)/COVID-19 like illness compared to not wearing masks (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.84 to 1.09; 9 trials, 276,917 participants; moderate-certainty evidence. Wearing masks in the community probably makes little or no difference to the outcome of laboratory-confirmed influenza/SARS-CoV-2 compared to not wearing masks (RR 1.01, 95% CI 0.72 to 1.42; 6 trials, 13,919 participants; moderate-certainty evidence). Harms were rarely measured and poorly reported (very low-certainty evidence). N95/P2 respirators compared to medical/surgical masks We pooled trials comparing N95/P2 respirators with medical/surgical masks (four in healthcare settings and one in a household setting). We are very uncertain on the effects of N95/P2 respirators compared with medical/surgical masks on the outcome of clinical respiratory illness (RR 0.70, 95% CI 0.45 to 1.10; 3 trials, 7779 participants; very low-certainty evidence). N95/P2 respirators compared with medical/surgical masks may be effective for ILI (RR 0.82, 95% CI 0.66 to 1.03; 5 trials, 8407 participants; low-certainty evidence). Evidence is limited by imprecision and heterogeneity for these subjective outcomes. The use of a N95/P2 respirators compared to medical/surgical masks probably makes little or no difference for the objective and more precise outcome of laboratory-confirmed influenza infection (RR 1.10, 95% CI 0.90 to 1.34; 5 trials, 8407 participants; moderate-certainty evidence). Restricting pooling to healthcare workers made no difference to the overall findings. Harms were poorly measured and reported, but discomfort wearing medical/surgical masks or N95/P2 respirators was mentioned in several studies (very low-certainty evidence).  One previously reported ongoing RCT has now been published and observed that medical/surgical masks were non-inferior to N95 respirators in a large study of 1009 healthcare workers in four countries providing direct care to COVID-19 patients.  Hand hygiene compared to control Nineteen trials compared hand hygiene interventions with controls with sufficient data to include in meta-analyses. Settings included schools, childcare centres and homes. Comparing hand hygiene interventions with controls (i.e. no intervention), there was a 14% relative reduction in the number of people with ARIs in the hand hygiene group (RR 0.86, 95% CI 0.81 to 0.90; 9 trials, 52,105 participants; moderate-certainty evidence), suggesting a probable benefit. In absolute terms this benefit would result in a reduction from 380 events per 1000 people to 327 per 1000 people (95% CI 308 to 342). When considering the more strictly defined outcomes of ILI and laboratory-confirmed influenza, the estimates of effect for ILI (RR 0.94, 95% CI 0.81 to 1.09; 11 trials, 34,503 participants; low-certainty evidence), and laboratory-confirmed influenza (RR 0.91, 95% CI 0.63 to 1.30; 8 trials, 8332 participants; low-certainty evidence), suggest the intervention made little or no difference. We pooled 19 trials (71, 210 participants) for the composite outcome of ARI or ILI or influenza, with each study only contributing once and the most comprehensive outcome reported. Pooled data showed that hand hygiene may be beneficial with an 11% relative reduction of respiratory illness (RR 0.89, 95% CI 0.83 to 0.94; low-certainty evidence), but with high heterogeneity. In absolute terms this benefit would result in a reduction from 200 events per 1000 people to 178 per 1000 people (95% CI 166 to 188). Few trials measured and reported harms (very low-certainty evidence). We found no RCTs on gowns and gloves, face shields, or screening at entry ports. AUTHORS' CONCLUSIONS: The high risk of bias in the trials, variation in outcome measurement, and relatively low adherence with the interventions during the studies hampers drawing firm conclusions. There were additional RCTs during the pandemic related to physical interventions but a relative paucity given the importance of the question of masking and its relative effectiveness and the concomitant measures of mask adherence which would be highly relevant to the measurement of effectiveness, especially in the elderly and in young children. There is uncertainty about the effects of face masks. The low to moderate certainty of evidence means our confidence in the effect estimate is limited, and that the true effect may be different from the observed estimate of the effect. The pooled results of RCTs did not show a clear reduction in respiratory viral infection with the use of medical/surgical masks. There were no clear differences between the use of medical/surgical masks compared with N95/P2 respirators in healthcare workers when used in routine care to reduce respiratory viral infection. Hand hygiene is likely to modestly reduce the burden of respiratory illness, and although this effect was also present when ILI and laboratory-confirmed influenza were analysed separately, it was not found to be a significant difference for the latter two outcomes. Harms associated with physical interventions were under-investigated. There is a need for large, well-designed RCTs addressing the effectiveness of many of these interventions in multiple settings and populations, as well as the impact of adherence on effectiveness, especially in those most at risk of ARIs.

Two Decades of Overuse and Underuse of Interventions for Primary and Secondary Prevention of Cardiovascular Diseases: A Systematic Review.

Quality use of anti-hypertensive and cholesterol-lowering medications is crucial for successful cardiovascular disease management. This systematic review aimed to estimate levels of over and underuse of services for primary and secondary prevention of cardiovascular diseases from 2000 to 2020: overprescribing/underprescribing, overtesting/undertesting and overutilization/ underutilization of procedures compared to clinical practice guideline recommendations. Thirteen studies from USA, Europe, Asia and Australia were included. Wide practice variation was identified. Six studies reported overuse (eg, perioperative cardiac consultations, anti-hypertensive overprescribing for normotensive or pre-hypertensive people); and ten studies reported underuse (eg, under-prescribing of statins when indicated and under-screening for familial hypercholesterolemia). Lifestyle recommendations for cardiovascular disease prevention were largely underused. In summary, lack of adherence to published guidelines was prevalent over the past 2 decades for both primary and secondary prevention across settings. Further investigation of potentially justifiable deviations from guidelines are warranted to verify the estimates and identify points for intervention.

Information about the natural history of acute infections commonly seen in primary care: a systematic review of clinical practice guidelines.

BACKGROUND: Many of the acute infections that are seen in primary care and sometimes managed with antibiotics are self-resolving and antibiotics may be unnecessary. Information about the natural history of these infections underpins antibiotic stewardship strategies such as delayed prescribing and shared decision making, yet whether it's reported in guidelines is unknown. We examined, in clinical guidelines, the reporting of natural history information and relevant antibiotic stewardship strategies for acute infections commonly seen in primary care. METHODS: A systematic review of national and international guidelines (2010 onwards), available electronically, for managing acute infections (respiratory, urinary, or skin and soft tissue). We searched MEDLINE, CINAHL, EMBASE, TRIP, and GIN databases and websites of 22 guideline-publishing organisations. RESULTS: We identified 82 guidelines, covering 114 eligible infections. Natural history information was reported in 49 (59.8%) of the guidelines and 66 (57.9%) of the reported conditions, most commonly for respiratory tract infections. Quantitative information about the expected infection duration was provided for 63.5% (n = 42) of the infections. Delayed antibiotic prescribing strategy was recommended for 34.2% (n = 39) of them and shared decision making for 21% (n = 24). CONCLUSIONS: Just over half of the guidelines for acute infections that are commonly managed in primary care and sometimes with antibiotics contained natural history information. As many of these infections spontaneously improve, this is a missed opportunity to disseminate this information to clinicians, promote antibiotic stewardship, and facilitate conversations with patients and informed decision making. Systematic review registration CRD42021247048.

A declaração PRISMA 2020: diretriz atualizada para relatar revisões sistemáticas*

[RESUMO]. A declaração dos Principais Itens para Relatar Revisões Sistemáticas e Meta-análises (PRISMA), publicada em 2009, foi desenvolvida para ajudar revisores sistemáticos a relatar de forma transparente por que a revisão foi feita, os métodos empregados e o que os autores encontraram. Na última década, os avanços na metodo- logia e terminologia de revisões sistemáticas exigiram a atualização da diretriz. A declaração PRISMA 2020 substitui a declaração de 2009 e inclui novas orientações para relato que refletem os avanços nos métodos para identificar, selecionar, avaliar e sintetizar estudos. A estrutura e apresentação dos itens foram modifi- cadas para facilitar a implementação. Neste artigo, apresentamos a lista de checagem PRISMA 2020 de 27 itens, uma lista de checagem expandida que detalha as recomendações para relato para cada item, a lista de checagem PRISMA 2020 para resumos e os fluxogramas revisados para novas revisões e para atualização de revisões.

[ABSTRACT]. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate imple- mentation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.

[RESUMEN]. La declaración PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses), publicada en 2009, se diseñó para ayudar a los autores de revisiones sistemáticas a documentar de manera transparente el porqué de la revisión, qué hicieron los autores y qué encontraron. Durante la última década, ha habido muchos avances en la metodología y terminología de las revisiones sistemáticas, lo que ha requerido una actualización de esta guía. La declaración PRISMA 2020 sustituye a la declaración de 2009 e incluye una nueva guía de presentación de las publicaciones que refleja los avances en los métodos para identificar, seleccionar, evaluar y sintetizar estudios. La estructura y la presentación de los ítems ha sido modificada para facilitar su implementación. En este artículo, presentamos la lista de verificación PRISMA 2020 con 27 ítems, y una lista de verificación ampliada que detalla las recomendaciones en la publicación de cada ítem, la lista de verificación del resumen estructurado PRISMA 2020 y el diagrama de flujo revisado para revisiones sistemáticas.