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We carried out a systematic review and meta-analysis to determine the effectiveness and safety of non-invasive electrical stimulation (NES) for vision restoration. We systematically searched for randomised controlled trials (RCTs) comparing NES with sham stimulation, for vision restoration between 2000 and 2022 in CENTRAL, MEDLINE, EMBASE, and LILACS. The main outcomes were as follows: visual acuity (VA); detection accuracy; foveal threshold; mean sensitivity as the parameter for the visual field; reading performance; contrast sensitivity (CS); electroencephalogram; quality of life (QoL), and safety. Two reviewers independently selected studies, extracted data, and evaluated the risk of bias using the Cochrane risk of bias 2.0 tool. The certainty in the evidence was determined using the GRADE framework. Protocol registration: CRD42022329342. Thirteen RCTs involving 441 patients with vision impairment indicate that NES may improve VA in the immediate post-intervention period (mean difference [MD] = -0.02 logMAR, 95% confidence intervals [CI] -0.08 to 0.04; low certainty), and probably increases QoL and detection accuracy (MD = 0.08, 95% CI -0.25 to 0.42 and standardised MD [SMD] = 0.09, 95% CI -0.58 to 0.77, respectively; both moderate certainty). NES likely results in little or no difference in mean sensitivity (SMD = -0.03, 95% CI -0.53 to 0.48). Compared with sham stimulation, NES increases the risk of minor adverse effects (risk ratio = 1.24, 95% CI 0.99 to 1.54; moderate certainty). The effect of NES on CS, reading performance, and electroencephalogram was uncertain. Our study suggests that although NES may slightly improve VA, detection accuracy, and QoL, the clinical relevance of these findings remains uncertain. Future research should focus on improving the available evidence's precision and consistency.

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BACKGROUND AND AIMS: Single-operator cholangioscopy (SOC) offer a diagnostic and therapeutic alternative with an improved optical resolution over conventional techniques; however, there are no standardized clinical practice guidelines for this technology. This evidence-based guideline from the Colombian Association of Digestive Endoscopy (ACED) intends to support patients, clinicians, and others in decisions about using in adults the SOC compared to endoscopic retrograde cholangiopancreatography (ERCP), to diagnose indeterminate biliary stricture and to manage difficult biliary stones. METHODS: ACED created a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. Universidad de los Andes and the Colombia Grading of Recommendations Assessment, Development and Evaluation (GRADE) Network supported the guideline-development process, updating and performing systematic evidence reviews. The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The GRADE approach was used, including GRADE Evidence-to-Decision frameworks. RESULTS: The panel agreed on one recommendation for adult patients with indeterminate biliary strictures and one for adult patients with difficult biliary stones when comparing SOC versus ERCP. CONCLUSION: For adult patients with indeterminate biliary strictures, the panel made a conditional recommendation for SOC with stricture pattern characterization over ERCP with brushing and/or biopsy for sensitivity, specificity, and procedure success rate outcomes. For the adult patients with difficult biliary stones the panel made conditional recommendation for SOC over ERCP with large-balloon dilation of papilla. Additional research is required on economic estimations of SOC and knowledge translation evaluations to implement SOC intervention in local contexts.

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Objective: To identify and assess the effect of community-based Knowledge Translation Strategies (KTS) on maternal, neonatal, and perinatal outcomes. Methods: We conducted systematic searches in Medline, Embase, CENTRAL, CINAHL, PsycInfo, LILACS, Wholis, Web of Science, ERIC, Jstor, and Epistemonikos. We assessed the certainty of the evidence of the studies using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. Results: We identified seven quantitative and seven qualitative studies. Quantitative findings suggest that there is a possible effect on reducing maternal mortality (RR 0.65; 95% CI, 0.48-0.87; moderate evidence certainty); neonatal mortality (RR 0.79; 95% CI 0.70-0.90; moderate evidence certainty); and perinatal mortality (RR 0.84; 95% CI 0.77-0.91; moderate evidence certainty) in women exposed to KTS compared to those who received conventional interventions or no intervention at all. Analysis of qualitative studies identified elements that allowed to generate benefit effects in improving maternal, neonatal, and perinatal outcomes. Conclusion: The KTS in maternal, neonatal, and perinatal outcomes might encourage the autonomy of communities despite that the certainty of evidence was moderate.

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BACKGROUND: The use of respiratory devices can mitigate the spread of diseases such as COVID-19 in community settings. We aimed to determine the effectiveness of closed face shields with surgical face masks to prevent SARS-CoV-2 transmission in working adults during the COVID-19 pandemic in Bogotá, Colombia. METHODS: An open-label non-inferiority randomized controlled trial that randomly assigned participants to one of two groups: the intervention group was instructed to wear closed face shields with surgical face masks, and the active control group was instructed to wear only surgical face masks. The primary outcome was a positive reverse transcription polymerase chain reaction test, IgG/IgM antibody test for SARS-CoV-2 detection, or both during and at the end of the follow-up period of 21 days. The non-inferiority limit was established at - 5%. RESULTS: A total of 316 participants were randomized, 160 participants were assigned to the intervention group and 156 to the active control group. In total, 141 (88.1%) participants in the intervention group and 142 (91.0%) in the active control group completed the follow-up. PRIMARY OUTCOME: a positive SARS-CoV-2 test result was identified in one (0.71%) participant in the intervention group and three (2.1%) in the active control group. In the intention-to-treat analysis, the absolute risk difference was - 1.40% (95% CI [- 4.14%, 1.33%]), and in the per-protocol analysis, the risk difference was - 1.40% (95% CI [- 4.20, 1.40]), indicating non-inferiority of the closed face shield plus face mask (did not cross the non-inferiority limit). CONCLUSIONS: The use of closed face shields and surgical face masks was non-inferior to the surgical face mask alone in the prevention of SARS-CoV-2 infection in highly exposed groups. Settings with highly active viral transmission and conditions such as poor ventilation, crowding, and high mobility due to occupation may benefit from the combined use of masks and closed face shields to mitigate SARS-CoV-2 transmission. TRIAL REGISTRATION: ClinicalTrials.gov NCT04647305 . Registered on November 30, 2020.

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BACKGROUND: An instrument to assess Allergic Rhinitis (AR) Health-Related Quality of Life (HRQL) in adult patients was developed in Spain. No validated instrument is currently cross-culturally adapted for use in daily practice to assess HRQL in AR patients in Colombia. PURPOSE: The aim of this study was to evaluate the measurement performance of an AR-HRQL specific questionnaire, ESPRINT-15 (Cuestionario ESPañol de Calidad de Vida en RINiTis), in Colombian adult patients with AR using the Classic Test Theory (CTT) and the Generalizability theory (G-theory) frameworks. METHODS: We conducted the cross-cultural adaptation in 2 stages. In stage 1, we evaluated comprehensibility, acceptability, and feasibility of ESPRINT-15 in healthy adults and adult patients with AR. In stage 2, we examined both reliability and validity of ESPRINT-15 scores using CTT and overall reliability applying the G-theory in adult patients with AR. RESULTS: For feasibility and acceptability, all items showed a higher than 95% level of understanding, and modifications in the original questionnaire were unnecessary. Reliability and validity using CTT showed a high internal consistency (Cronbach's alpha and Mc McDonald's omega = 0.95) and test-retest reliability (scores from 0.70 to 0.76). The overall reliability score using G-theory was 0.75, and G-coefficients scores associated with internal consistency and test-retest reliability measures were 0.96 and 0.61, respectively. Validity using exploratory factor analysis (EFA) identified 2 factors instead of the original ESPRINT-15 4 domains. However, confirmatory factor analysis (CFA) showed good fit regarding the original model. CONCLUSIONS: The proposed cross-cultural adaptation of ESPRINT-15 showed good reliability and validity measures. Additionally, it was easy to use and administer. ESPRINT-15 can be used clinically and for research in Colombian adults' patients with AR. CTT and the G-theory can be used in epidemiological studies to adapt AR-HRQL questionnaires cross-culturally in adult patients with AR.

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BACKGROUND: The coronavirus disease 19 (covid-19) pandemic has underscored the need to expedite clinical research, which may lead investigators to shift away from measuring patient-important outcomes (PIO), limiting research applicability. We aim to investigate if randomized controlled trials (RCTs) of covid-19 pharmacological therapies include PIOs. METHODS: We will perform a meta-epidemiological study of RCTs that included people at risk for, or with suspected, probable, or confirmed covid-19, examining any pharmacological treatment or blood product aimed at prophylaxis or treatment. We will obtain data from all RCTs identified in a living network metanalysis (NMA). The main data sources are the living WHO covid-19 database up to 1 March 2021 and six additional Chinese databases up to 20 February 2021. Two reviewers independently will review each citation, full-text article, and abstract data. To categorize the outcomes according to their importance to patients, we will adapt a previously defined hierarchy: a) mortality, b) quality of life/ functional status/symptoms, c) morbidity, and d) surrogate outcomes. Outcomes within the category a) and b) will be considered critically important to patients, and outcomes within the category c) will be regarded as important. We will use descriptive statistics to assess the proportion of studies that report each category of outcomes. We will perform univariable and multivariable analysis to explore associations between trial characteristics and the likelihood of reporting PIOs. DISCUSSION: The findings from this meta-epidemiological study will help health care professionals and researchers understand if the current covid-19 trials are effectively assessing and reporting the outcomes that are important to patients. If a deficiency in capturing PIOs is identified, this information may help inform the development of future RCTs in covid-19. SYSTEMATIC REVIEW REGISTRATIONS: Open Science Framework registration: osf.io/6xgjz .

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BACKGROUND: Atopic dermatitis (AD) is an inflammatory chronic condition that affects the skin of children and adults and has an important impact on the quality of life. Treatments for AD are based on environmental controls, topical and systemic therapies, and allergen-specific immunotherapy (AIT). However, it remains unclear the effectiveness and adverse events of AIT and all conventional topical treatments compared with placebo and each other for AD. METHODS: We will search five electronic databases [Central Cochrane register of controlled trials (CENTRAL), MEDLINE, EMBASE, CINAHL, and LILACS] from inception until November 2019 with no language restriction, and we will include experimental studies [randomized controlled trials (RCTs), and quasi-RCTs]. The primary outcome is global and specific skin symptoms assessment. Secondary outcomes are hospital length of stay, quality of life, and adverse events. Reviewers independently will extract data from the studies that meet our inclusion criteria and will assess the risk of bias of individual primary studies. We will conduct random effects pairwise meta-analyses for the observed pairwise comparisons with at least two trials. Then, we will perform random-effects Bayesian network meta-analysis (NMA) to obtain treatment effects for all possible comparisons and to provide a hierarchy of all interventions for each outcome. Possible incoherence between direct and indirect sources of evidence will be investigated locally (if possible) and globally. To investigate sources of statistical heterogeneity, we will perform a series of meta-regression analyses based on pre-specified important effect modifiers. Two authors will appraise the certainty of the evidence for each outcome applying the GRADE's framework for NMA. DISCUSSION: The findings of this systematic review will shed the light on the effectiveness and adverse events of all possible comparisons for treating AD and on the quality of the collated evidence for recommendations. It will also provide critical information to health care professionals to comprehend and manage this disease at different age stages, treatment type, duration, and severity of atopic dermatitis. SYSTEMATIC REVIEW REGISTRATION: PROSPERO Protocol ID CRD42019147106.

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OBJECTIVES: The aim of the study was to develop a Grading of Recommendations, Assessment, Development and Evaluation (GRADE) summary of findings (SoF) table format that displays the critical information from a network meta-analysis (NMA). STUDY DESIGN AND SETTING: We applied a user experience model for data analysis based on four rounds of semistructured interviews. RESULTS: We interviewed 32 stakeholders who conduct or use MA. Four rounds of interviews produced six candidate NMA-SoF tables. Users found a final NMA-SoF table that included the following components highly acceptable: (1) details of the clinical question (PICO), (2) a plot depicting network geometry, (3) relative and absolute effect estimates, (4) certainty of evidence, (5) ranking of treatments, and (6) interpretation of findings. CONCLUSION: Using stakeholder feedback, we developed a new GRADE NMA-SoF table that includes the relevant components that facilitate understanding NMA findings and health decision-making.

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OBJECTIVES: In systematic reviews of studies of patients' values and preferences, the objective of the study was to summarize items and domains authors have identified when considering the risk of bias (RoB) associated with primary studies. STUDY DESIGN AND SETTING: We conducted a systematic survey of systematic reviews of patients' values and preference studies. Our search included three databases (MEDLINE, EMBASE, and PsycINFO) from their inception to August 2015. We conducted duplicate data extraction, focusing on items that authors used to address RoB in the primary studies included in their reviews and the associated underlying domains, and summarized criteria in descriptive tables. RESULTS: We identified 42 eligible systematic reviews that addressed 23 items relevant to RoB and grouped the items into 7 domains: appropriate administration of instrument; instrument choice; instrument-described health state presentation; choice of participants group; description, analysis, and presentation of methods and results; patient understanding; and subgroup analysis. CONCLUSION: The items and domains identified provide insight into issues of RoB in patients' values and preference studies and establish the basis for an instrument to assess RoB in such studies.

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