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.

Mapping the evidence about the natural history of acute infections commonly seen in primary care and managed with antibiotics: a scoping review.

BACKGROUND: Knowing the natural history of acute infections in primary care, defined as the course of a disease over time in the absence of specific therapy or treatment, can inform clinicians' and patients' expectations about illness recovery, but this evidence is fragmented across the literature. This scoping review aimed to map existing research and research gaps relevant to the natural history of acute infections. METHODS: We searched MEDLINE, Embase and CENTRAL using a 2-phase hierarchical search approach. In Phase A, we focused on identifying systematic reviews synthesising natural history data for eligible infections (acute respiratory, urinary, and skin and soft tissue) and systematic reviews of treatment effectiveness (of RCTs with placebo or no treatment arm, or cohort studies). For infections without existing reviews, in Phase B, we searched for primary studies (placebo-controlled RCTs or cohort studies). Two reviewers independently screened and extracted the data (study characteristics, outcome data - e.g., symptom duration, proportion with resolution at various time points). RESULTS: We identified 40 systematic reviews, reporting on 45 infections, most commonly (90%) respiratory tract infections. Six (15%) of these aimed to synthesise natural history information. Most reviews reported the proportion of participants with symptom resolution at various time point/s, with 58% providing data on mean symptom duration. Recovery data show the spontaneous resolution of some infections in some people. We found no eligible studies for cellulitis, ecthyma, carbuncle, and erysipelas. CONCLUSIONS: Our review has shown that natural history evidence exists for many common acute infections. It can be utilised by clinicians in implementing patient-centred antibiotic stewardship strategies in primary care. Future research should focus on generating natural history evidence for skin and soft tissue infections and urinary tract infections.

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.

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.

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.

A Brief Shared Decision-Making Intervention for Acute Respiratory Infections on Antibiotic Dispensing Rates in Primary Care: A Cluster Randomized Trial.

PURPOSE: To determine whether acute respiratory infection (ARI) decision aids and a general practitioner (GP) training package reduces antibiotic dispensing rate and improves GPs' knowledge of antibiotic benefit-harm evidence. METHODS: A cluster randomized trial of 27 Australian general practices (13 intervention, 14 control) involving 122 GPs. Intervention group GPs were given brief decision aids for 3 ARIs (acute otitis media, acute sore throat, acute bronchitis) and video-delivered training. Primary outcome was dispensing rate of target antibiotic classes (routinely used for ARIs), extracted for 12 months before, and following, randomization. Secondary outcomes were GPs' knowledge of antibiotic benefit-harm evidence; prescribing influences; acceptability, usefulness, and self-reported resource use; and dispensing rate of all antibiotics. RESULTS: The baseline mean dispensing rate of ARI-related antibiotics was 3.5% (intervention GPs) and 3.2% (control GPs) of consultations. After 12 months, mean rates decreased (to 2.9% intervention; 2.6% control): an 18% relative reduction from baseline but similar in both groups (rate ratio 1.01; 95% CI, 0.89-1.15). Greater increases in knowledge were seen in the intervention group than control; a significant increase (average 3.6; 95% CI, 2.4-4.7, P <.001) in the number of correct responses to the 22 knowledge questions. There were no between-group differences for other secondary outcomes. The intervention was well received, perceived as useful, and reported as used by about two-thirds of intervention GPs. CONCLUSIONS: A brief shared decision-making intervention provided to GPs did not reduce antibiotic dispensing more than usual care, although GPs' knowledge of relevant benefit-harm evidence increased significantly.

TIDieR-telehealth: precision in reporting of telehealth interventions used in clinical trials - unique considerations for the Template for the Intervention Description and Replication (TIDieR) checklist.

BACKGROUND: Recent international health events have led to an increased proliferation of remotely delivered health interventions. Even with the pandemic seemingly coming under control, the experiences of the past year have fueled a growth in ideas and technology for increasing the scope of remote care delivery. Unfortunately, clinicians and health systems will have difficulty with the adoption and implementation of these interventions if ongoing and future clinical trials fail to report necessary details about execution, platforms, and infrastructure related to these interventions. The purpose was to develop guidance for reporting of telehealth interventions. METHODS: A working group from the US Pain Management Collaboratory developed guidance for complete reporting of telehealth interventions. The process went through 5-step process from conception to final checklist development with input for many stakeholders, to include all 11 primary investigators with trials in the Collaboratory. RESULTS: An extension focused on unique considerations relevant to telehealth interventions was developed for the Template for the Intervention Description and Replication (TIDieR) checklist. CONCLUSION: The Telehealth Intervention guideline encourages use of the Template for the Intervention Description and Replication (TIDieR) checklist as a valuable tool (TIDieR-Telehealth) to improve the quality of research through a reporting guide of relevant interventions that will help maximize reproducibility and implementation.

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.

Occupational therapy for cognitive impairment in stroke patients.

BACKGROUND: Cognitive impairment is a frequent consequence of stroke and can impact on a person's ability to perform everyday activities. Occupational therapists use a range of interventions when working with people who have cognitive impairment poststroke. This is an update of a Cochrane Review published in 2010. OBJECTIVES: To assess the impact of occupational therapy on activities of daily living (ADL), both basic and instrumental, global cognitive function, and specific cognitive abilities in people who have cognitive impairment following a stroke. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, Embase, four other databases (all last searched September 2020), trial registries, and reference lists. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials that evaluated an intervention for adults with clinically defined stroke and confirmed cognitive impairment. The intervention needed either to be provided by an occupational therapist or considered within the scope of occupational therapy practice as defined in the review. We excluded studies focusing on apraxia or perceptual impairments or virtual reality interventions as these are covered by other Cochrane Reviews. The primary outcome was basic activities of daily living (BADL) such as dressing, feeding, and bathing. Secondary outcomes were instrumental ADL (IADL) (e.g. shopping and meal preparation), community integration and participation, global cognitive function and specific cognitive abilities (including attention, memory, executive function, or a combination of these), and subdomains of these abilities. We included both observed and self-reported outcome measures. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies that met the inclusion criteria, extracted data, and assessed the certainty of the evidence. A third review author moderated disagreements if consensus was not reached. We contacted trial authors for additional information and data, where available. We assessed the certainty of key outcomes using GRADE.  MAIN RESULTS: We included 24 trials from 11 countries involving 1142 (analysed) participants (two weeks to eight years since stroke onset). This update includes 23 new trials in addition to the one study included in the previous version. Most were parallel randomised controlled trials except for one cross-over trial and one with a two-by-two factorial design. Most studies had sample sizes under 50 participants. Twenty studies involved a remediation approach to cognitive rehabilitation, particularly using computer-based interventions. The other four involved a compensatory and adaptive approach. The length of interventions ranged from 10 days to 18 weeks, with a mean total length of 19 hours. Control groups mostly received usual rehabilitation or occupational therapy care, with a few receiving an attention control that was comparable to usual care; two had no intervention (i.e. a waiting list). Apart from high risk of performance bias for all but one of the studies, the risk of bias for other aspects was mostly low or unclear.  For the primary outcome of BADL, meta-analysis found a small effect on completion of the intervention with a mean difference (MD) of 2.26 on the Functional Independence Measure (FIM) (95% confidence interval (CI) 0.17 to 4.22; P = 0.03, I2 = 0%; 6 studies, 336 participants; low-certainty evidence). Therefore, on average, BADL improved by 2.26 points on the FIM that ranges from 18 (total assist) to 126 (complete independence). On follow-up, there was insufficient evidence of an effect at three months (MD 10.00, 95% CI -0.54 to 20.55; P = 0.06, I2 = 53%; 2 studies, 73 participants; low-certainty evidence), but evidence of an effect at six months (MD 11.38, 95% CI 1.62 to 21.14, I2 = 12%; 2 studies, 73 participants; low-certainty evidence). These differences are below 22 points which is the established minimal clinically important difference (MCID) for the FIM for people with stroke. For IADL, the evidence is very uncertain about an effect (standardised mean difference (SMD) 0.94, 95% CI 0.41 to 1.47; P = 0.0005, I2 = 98%; 2 studies, 88 participants). For community integration, we found insufficient evidence of an effect (SMD 0.09, 95% CI -0.35 to 0.54; P = 0.68, I2 = 0%; 2 studies, 78 participants). There was an improvement of clinical importance in global cognitive functional performance after the intervention (SMD 0.35, 95% CI 0.16 to 0.54; P = 0.0004, I2 = 0%; 9 studies, 432 participants; low-certainty evidence), equating to 1.63 points on the Montreal Cognitive Assessment (MoCA) (95% CI 0.75 to 2.52), which exceeds the anchor-based MCID of the MoCA for stroke rehabilitation patients of 1.22. We found some effect for attention overall (SMD -0.31, 95% CI -0.47 to -0.15; P = 0.0002, I2 = 20%; 13 studies, 620 participants; low-certainty evidence), equating to a difference of 17.31 seconds (95% CI 8.38 to 26.24), and for executive functional performance overall (SMD 0.49, 95% CI 0.31 to 0.66; P < 0.00001, I2 = 74%; 11 studies, 550 participants; very low-certainty evidence), equating to 1.41 points on the Frontal Assessment Battery (range: 0-18). Of the cognitive subdomains, we found evidence of effect of possible clinical importance, immediately after intervention, for sustained visual attention (moderate certainty) equating to 15.63 seconds, for working memory (low certainty) equating to 59.9 seconds, and thinking flexibly (low certainty), compared to control. AUTHORS' CONCLUSIONS: The effectiveness of occupational therapy for cognitive impairment poststroke remains unclear. Occupational therapy may result in little to no clinical difference in BADL immediately after intervention and at three and six months' follow-up. Occupational therapy may slightly improve global cognitive performance of a clinically important difference immediately after intervention, likely improves sustained visual attention slightly, and may slightly increase working memory and flexible thinking after intervention. There is evidence of low or very low certainty or insufficient evidence for effect on other cognitive domains, IADL, and community integration and participation.  Given the low certainty of much of the evidence in our review, more research is needed to support or refute the effectiveness of occupational therapy for cognitive impairment after stroke. Future trials need improved methodology to address issues including risk of bias and to better report the outcome measures and interventions used.

Using qualitative research to develop an elaboration of the TIDieR checklist for interventions to enhance vaccination communication: short report.

BACKGROUND: The COVID-19 pandemic has led to an increased interest in communication with the public regarding vaccination. Our recent Cochrane qualitative evidence synthesis points to several factors that could influence the implementation and success of healthcare worker communication with older adults about vaccination. However, it is often difficult to assess whether factors identified as potentially important in qualitative studies have been considered in randomized trials because of poor trial reporting. We therefore decided to use our qualitative evidence synthesis findings to encourage better reporting of vaccination communication interventions in trials by developing an elaboration of the TIDieR (Template for Intervention Description and Replication) checklist for intervention reporting. METHODS: We examined the findings from our Cochrane qualitative evidence synthesis on healthcare workers' perceptions of and experiences with communicating about vaccination with adults over the age of 50 years. We identified factors that could influence the implementation and uptake, and thereby the effectiveness, of vaccination communication interventions. We then drafted a list of the information elements we would need from trial reports to assess whether these factors had been considered in the development of the interventions evaluated in these trials. Finally, we compared our list of information elements to the TIDieR checklist items. We were able to align all of our information elements with the TIDieR items. However, for several of the TIDieR items, we developed a more detailed description to ensure that relevant information would be captured sufficiently in trial reports. RESULTS: We developed elaborations for the following TIDieR items: "Why" (item 2), "What-materials" (item 3), "Who provided" (item 5), "How" (item 6), "Where" (item 7) and "Tailoring" (item 9). CONCLUSIONS: Both qualitative research and trials of intervention effectiveness are critical to furthering our understanding of what works, where, for whom and through which mechanisms. However, a key ingredient for developing this understanding is adequate reporting of intervention design, content and implementation in randomized trials. We hope that this elaboration of the TIDier checklist will improve reporting of interventions in trials focused on vaccine communication with older adults, and thereby enhance the usability of this research for developing future communication strategies.

[The PRISMA 2020 statement: an updated guideline for reporting systematic reviewsDeclaración PRISMA 2020: una guía actualizada para la publicación de revisiones sistemáticas]. / A declaração PRISMA 2020: diretriz atualizada para relatar revisões sistemáticas.

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 implementation. 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.

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.

Advancing Stroke Recovery Through Improved Articulation of Nonpharmacological Intervention Dose.

Dose articulation is a universal issue of intervention development and testing. In stroke recovery, dose of a nonpharmaceutical intervention appears to influence outcome but is often poorly reported. The challenges of articulating dose in nonpharmacological stroke recovery research include: (1) the absence of specific internationally agreed dose reporting guidelines; (2) inadequate conceptualization of dose, which is multidimensional; and (3) unclear and inconsistent terminology that incorporates the multiple dose dimensions. To address these challenges, we need a well-conceptualized and consistent approach to dose articulation that can be applied across stroke recovery domains to stimulate critical thinking about dose during intervention development, as well as promote reporting of planned intervention dose versus actually delivered dose. We followed the Design Research Paradigm to develop a framework that guides how to articulate dose, conceptualizes the multidimensional nature and systemic linkages between dose dimensions, and provides reference terminology for the field. Our framework recognizes that dose is multidimensional and comprised of a duration of days that contain individual sessions and episodes that can be active (time on task) or inactive (time off task), and each individual episode can be made up of information about length, intensity, and difficulty. Clinical utility of this framework was demonstrated via hypothetical application to preclinical and clinical domains of stroke recovery. The suitability of the framework to address dose articulation challenges was confirmed with an international expert advisory group. This novel framework provides a pathway for better articulation of nonpharmacological dose that will enable transparent and accurate description, implementation, monitoring, and reporting, in stroke recovery research.

The PRISMA 2020 statement: An updated guideline for reporting systematic reviews.

Matthew Page and co-authors describe PRISMA 2020, an updated reporting guideline for systematic reviews and meta-analyses.

Processes for evidence summarization for patient decision aids: A Delphi consensus study.

BACKGROUND: Patient decision aids (PDAs) should provide evidence-based information so patients can make informed decisions. Yet, PDA developers do not have an agreed-upon process to select, synthesize and present evidence in PDAs. OBJECTIVE: To reach the consensus on an evidence summarization process for PDAs. DESIGN: A two-round modified Delphi survey. SETTING AND PARTICIPANTS: A group of international experts in PDA development invited developers, scientific networks, patient groups and listservs to complete Delphi surveys. DATA COLLECTION: We emailed participants the study description and a link to the online survey. Participants were asked to rate each potential criterion (omit, possible, desirable, essential) and provide qualitative feedback. ANALYSIS: Criteria in each round were retained if rated by >80% of participants as desirable or essential. If two or more participants suggested rewording, reordering or merging, the steering group considered the suggestion. RESULTS: Following two Delphi survey rounds, the evidence summarization process included defining the decision, reporting the processes and policies of the evidence summarization process, assembling the editorial team and managing (collect, manage, report) their conflicts of interest, conducting a systematic search, selecting and appraising the evidence, presenting the harms and benefits in plain language, and describing the method of seeking external review and the plan for updating the evidence (search, selection and appraisal of new evidence). CONCLUSION: A multidisciplinary stakeholder group reached consensus on an evidence summarization process to guide the creation of high-quality PDAs. PATIENT CONTRIBUTION: A patient partner was part of the steering group and involved in the development of the Delphi survey.

Preprints in times of COVID19: the time is ripe for agreeing on terminology and good practices.

Over recent years, the research community has been increasingly using preprint servers to share manuscripts that are not yet peer-reviewed. Even if it enables quick dissemination of research findings, this practice raises several challenges in publication ethics and integrity. In particular, preprints have become an important source of information for stakeholders interested in COVID19 research developments, including traditional media, social media, and policy makers. Despite caveats about their nature, many users can still confuse pre-prints with peer-reviewed manuscripts. If unconfirmed but already widely shared first-draft results later prove wrong or misinterpreted, it can be very difficult to "unlearn" what we thought was true. Complexity further increases if unconfirmed findings have been used to inform guidelines. To help achieve a balance between early access to research findings and its negative consequences, we formulated five recommendations: (a) consensus should be sought on a term clearer than 'pre-print', such as 'Unrefereed manuscript', "Manuscript awaiting peer review" or ''Non-reviewed manuscript"; (b) Caveats about unrefereed manuscripts should be prominent on their first page, and each page should include a red watermark stating 'Caution-Not Peer Reviewed'; (c) pre-print authors should certify that their manuscript will be submitted to a peer-review journal, and should regularly update the manuscript status; (d) high level consultations should be convened, to formulate clear principles and policies for the publication and dissemination of non-peer reviewed research results; (e) in the longer term, an international initiative to certify servers that comply with good practices could be envisaged.

Effect of different visual presentations on the comprehension of prognostic information: a systematic review.

BACKGROUND: Understanding prognostic information can help patients know what may happen to their health over time and make informed decisions. However, communicating prognostic information well can be challenging. PURPOSE: To conduct a systematic review to identify and synthesize research that has evaluated visual presentations that communicate quantitative prognostic information to patients or the public. DATA SOURCES: MEDLINE, EMBASE, CINAHL, PsycINFO, ERIC and the Cochrane Central Register of Controlled Trials (CENTRAL) (from inception to December 2020), and forward and backward citation search. STUDY SELECTION: Two authors independently screened search results and assessed eligibility. To be eligible, studies required a quantitative design and comparison of at least one visual presentation with another presentation of quantitative prognostic information. The primary outcome was comprehension of the presented information. Secondary outcomes were preferences for or satisfaction with the presentations viewed, and behavioral intentions. DATA EXTRACTION: Two authors independently assessed risk of bias and extracted data. DATA SYNTHESIS: Eleven studies (all randomized trials) were identified. We grouped studies according to the presentation type evaluated. Bar graph versus pictograph (3 studies): no difference in comprehension between the groups. Survival vs mortality curves (2 studies): no difference in one study; higher comprehension in survival curve group in another study. Tabular format versus pictograph (4 studies): 2 studies reported similar comprehension between groups; 2 found higher comprehension in pictograph groups. Tabular versus free text (3 studies): 2 studies found no difference between groups; 1 found higher comprehension in a tabular group. LIMITATIONS: Heterogeneity in the visual presentations and outcome measures, precluding meta-analysis. CONCLUSIONS: No visual presentation appears to be consistently superior to communicate quantitative prognostic information.

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls.

BACKGROUND: Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions. METHODS AND FINDINGS: We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator. CONCLUSIONS: We encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.

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 published in 2007, 2009, 2010, and 2011. The evidence summarised in this review does not 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 on 1 April 2020. We searched ClinicalTrials.gov, and the WHO ICTRP on 16 March 2020. We conducted a backwards and forwards citation analysis on the newly included studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and cluster-RCTs of trials investigating physical interventions (screening at entry ports, isolation, quarantine, physical distancing, personal protection, hand hygiene, face masks, and gargling) to prevent respiratory virus transmission. In previous versions of this review we also included observational studies. However, for this update, there were sufficient RCTs to address our study aims.   DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of the evidence. Three pairs of review authors independently extracted data using a standard template applied in previous versions of this review, but which was revised to reflect our focus on RCTs and cluster-RCTs for this update. We did not contact trialists for missing data due to the urgency in completing the review. We extracted data on adverse events (harms) associated with the interventions. MAIN RESULTS: We included 44 new RCTs and cluster-RCTs in this update, bringing the total number of randomised trials to 67. There were no included studies conducted during the COVID-19 pandemic. Six ongoing studies were identified, of which three evaluating masks are being conducted concurrent with the COVID pandemic, and one is completed. Many studies were conducted during non-epidemic influenza periods, but several studies were conducted during the global H1N1 influenza pandemic in 2009, and others in epidemic influenza seasons up to 2016. Thus, 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. Compliance 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 nine trials (of which eight were cluster-RCTs) comparing medical/surgical masks versus no masks to prevent the spread of viral respiratory illness (two trials with healthcare workers and seven in the community). There is low certainty evidence from nine trials (3507 participants) that wearing a mask may make little or no difference to the outcome of influenza-like illness (ILI) compared to not wearing a mask (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.82 to 1.18. There is moderate certainty evidence that wearing a mask probably makes little or no difference to the outcome of laboratory-confirmed influenza compared to not wearing a mask (RR 0.91, 95% CI 0.66 to 1.26; 6 trials; 3005 participants). Harms were rarely measured and poorly reported. Two studies during COVID-19 plan to recruit a total of 72,000 people. One evaluates medical/surgical masks (N = 6000) (published Annals of Internal Medicine, 18 Nov 2020), and one evaluates cloth masks (N = 66,000). 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). There is uncertainty over the effects of N95/P2 respirators when compared with medical/surgical masks on the outcomes of clinical respiratory illness (RR 0.70, 95% CI 0.45 to 1.10; very low-certainty evidence; 3 trials; 7779 participants) and ILI (RR 0.82, 95% CI 0.66 to 1.03; low-certainty evidence; 5 trials; 8407 participants). The evidence is limited by imprecision and heterogeneity for these subjective outcomes. The use of a N95/P2 respirator compared to a medical/surgical mask 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; moderate-certainty evidence; 5 trials; 8407 participants). Restricting the 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. One ongoing study recruiting 576 people compares N95/P2 respirators with medical surgical masks for healthcare workers during COVID-19. Hand hygiene compared to control Settings included schools, childcare centres, homes, and offices. In a comparison of hand hygiene interventions with control (no intervention), there was a 16% relative reduction in the number of people with ARIs in the hand hygiene group (RR 0.84, 95% CI 0.82 to 0.86; 7 trials; 44,129 participants; moderate-certainty evidence), suggesting a probable benefit. When considering the more strictly defined outcomes of ILI and laboratory-confirmed influenza, the estimates of effect for ILI (RR 0.98, 95% CI 0.85 to 1.13; 10 trials; 32,641 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 all 16 trials (61,372 participants) for the composite outcome of ARI or ILI or influenza, with each study only contributing once and the most comprehensive outcome reported. The pooled data showed that hand hygiene may offer a benefit with an 11% relative reduction of respiratory illness (RR 0.89, 95% CI 0.84 to 0.95; low-certainty evidence), but with high heterogeneity. Few trials measured and reported harms. There are two ongoing studies of handwashing interventions in 395 children outside of COVID-19. We identified one RCT on quarantine/physical distancing. Company employees in Japan were asked to stay at home if household members had ILI symptoms. Overall fewer people in the intervention group contracted influenza compared with workers in the control group (2.75% versus 3.18%; hazard ratio 0.80, 95% CI 0.66 to 0.97). However, those who stayed at home with their infected family members were 2.17 times more likely to be infected. We found no RCTs on eye protection, gowns and gloves, or screening at entry ports. AUTHORS' CONCLUSIONS: The high risk of bias in the trials, variation in outcome measurement, and relatively low compliance with the interventions during the studies hamper drawing firm conclusions and generalising the findings to the current COVID-19 pandemic. There is uncertainty about the effects of face masks. The low-moderate certainty of the 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 randomised trials did not show a clear reduction in respiratory viral infection with the use of medical/surgical masks during seasonal influenza. 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. 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, especially in those most at risk of ARIs.

Inadequate description of placebo and sham controls in a systematic review of recent trials.

BACKGROUND: Poorly described placebo/sham controls make it difficult to appraise active intervention benefits and harms. The 12-item Template for Intervention Description and Replication (TIDieR) checklist was developed to improve the reporting of active interventions. The extent to which TIDieR has been used to improve description of placebo or sham control is not known. MATERIALS AND METHODS: We systematically identified and examined all placebo/sham-controlled randomised trials published in 2018 in the top six general medical journals. We reported how many of the TIDieR checklist items were used to describe the placebo/sham control(s). We supplemented this with a sample of 100 placebo/sham-controlled trials from any journal and searched Google Scholar to identify placebo/sham-controlled trials citing TIDieR. RESULTS: We identified 94 placebo/sham-controlled trials published in the top journals in 2018. None reported using TIDieR, and none reported placebo or sham components completely. On average eight TIDieR items were addressed, with placebo/sham control name (100%) and when and how much was administered (97.9%) most commonly reported. Some items (rationale, 8.5%, whether there were modifications, 25.5%) were less often reported. In our sample of less well-cited journals, reporting was poorer (average of six items) and followed a similar pattern. Since TIDieR's first publication, six placebo-controlled trials have cited it according to Google Scholar. Two of these used the checklist to describe placebo controls; neither one completely desribed the placebo intervention. CONCLUSIONS: Placebo and sham controls are poorly described within randomised trials, and TIDieR is rarely used to guide these descriptions. We recommend developing guidelines to promote better descriptions of placebo/sham control components within clinical trials.

Blue-Light Therapy for Acne Vulgaris: A Systematic Review and Meta-Analysis.

PURPOSE: Antibiotic use in acne treatment raises concerns about increased resistance, necessitating alternatives. We assessed the effectiveness of blue-light therapy for acne. METHODS: We analyzed randomized controlled trials comparing blue light with nonlight interventions. Studies included people of any age, sex, and acne severity, in any setting, and reported on investigator-assessed change in acne severity, patients' assessment of improvement, change in inflammatory or noninflammatory lesions, and adverse events. Where data were sufficient, mean differences were calculated. RESULTS: Eighteen references (14 trials) including 698 participants were included. Most of the trials were small and short (<12 weeks) and had high risk of bias. Investigator-assessed improvement was quantitatively reported in 5 trials, of which 3 reported significantly greater improvement in blue light than comparator, and 2 reported improvement. Patients' assessments of improvement were quantitatively reported by 2 trials, favoring blue light. Mean difference in the mean number of noninflammatory lesions was nonsignificant between groups at weeks 4, 8, and 10-12 and overall (mean difference [MD] = 3.47; 95% CI, -0.76 to 7.71; P = 0.11). Mean difference in the mean number of inflammatory lesions was likewise nonsignificant between groups at any of the time points and overall (MD = 0.16; 95% CI, -0.99 to 1.31; P = 0.78). Adverse events were generally mild and favored blue light or did not significantly differ between groups. CONCLUSION: Methodological and reporting limitations of existing evidence limit conclusions about the effectiveness of blue light for acne. Clinicians and patients should therefore consider the balance between its benefits and adverse events, as well as costs.