Effect of synbiotics on inflammatory markers and white blood cell count in COVID-19 patients: a randomized, double-blind, placebo-controlled clinical trial. (Special Issue: The relationship between nutrition and COVID-19.)

Purpose: Today, coronavirus disease-19 (COVID-19) treatment is an evolving process, and synbiotic administration has been suggested as a new therapeutic strategy. This study aims to investigate the effect of synbiotic supplementation in COVID-19 patients. Design/methodology/approach: In this placebo-controlled trial, 80 patients were randomized to receive oral synbiotic capsule (containing fructooligosaccharide and seven bacterial strains;Lactobacillus (L) casei, L. rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, L. acidophilus, Bifidobacterium longum, L. bulgaricus, each one 109 colony-forming units) or placebo for two months. Inflammatory markers (Interleukin-6 [IL-6], C-reactive protein [CRP], erythrocyte sedimentation rate [ESR]) and white blood cell (WBC) count were evaluated at two timepoints (baseline, two months later). The measured variables were adjusted for confounders and analyzed by SPSS v21.0. Findings: All 80 enrolled patients completed the study. The study adherence was good (approximately 70%). The mean changes for IL-6 were not significant ( = -0.6 +or- 10.4 pg/mL vs = +11.2 +or- 50.3 pg/mL, p > 0.05). There were no significant improvements for CRP, ESR and WBC. Originality/value: Administration of synbiotics for two months did not improve inflammatory markers in COVID-19 patients.

Special Issue: The relationship between nutrition and COVID-19. (Special Issue: The relationship between nutrition and COVID-19.)

This special issue contains 8 articles that discuss and highlights the importance of nutrition in mitigating the mental and health-related issues associated with the pandemic, as well as its effects on diet quality and physical activity levels. Topics include: (1) a systematic literature review that emphasizes the role of nutrition in minimizing mental and health-related issues during COVID-19. The review concludes that a healthy diet rich in essential nutrients can play a crucial role in supporting mental health, immune function and overall well-being during the pandemic. In addition, it highlights the need for public health interventions that promote healthy eating habits and provide access to nutritious foods, (2) adherence to the Mediterranean diet in Greek adolescents during COVID-19, (3) a randomized, double-blind, placebo-controlled clinical trial investigated the effect of synbiotics on inflammatory markers and white blood cell count in COVID-19 patients, (4) COVID-19 pandemic anxiety was reflected in nutritional habits in adults, (5) investigation of the link between metabolic risks, dietary patterns and COVID-19 prognosis, (6) exploration of the factors related to sedentary lifestyle in a Brazilian sample during the COVID-19 initial quarantine.

Efficacy and Safety of Molnupiravir Treatment for COVID-19: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

INTRODUCTION: There are currently some differences in the research results of molnupiravir. This study aimed to evaluate the efficacy and safety of molnupiravir in the treatment of COVID-19. METHODS: PubMed, Embase, CENTRAL (Cochrane Central Register of Controlled Trials), ClinicalTrials.gov, ICTRP (International Clinical Trials Registry Platform) and medRxiv were searched to identify relevant randomised controlled trials (RCTs) from inception to 1 January 2023. The Cochrane risk of bias tool for randomised trials was used to assess the bias risk of the included studies. Revman 5.4 software was used for meta-analysis. RESULTS: Nine RCTs were included, including 31 573 COVID-19 patients, of whom 15 846 received molnupiravir. The meta-analysis results showed that the molnupiravir group had a higher proportion in terms of clinical improvement (Day 5 RR 2.41, 95% CI 1.18-4.92; Day 10 RR 1.45, 95% CI 1.04-2.01) and real-time polymerase chain reaction negativity (Day 5 RR 2.78, 95% CI 1.38-5.62; Day 10 RR 1.18, 95% CI 1.07-1.31). However, no significant difference was observed between the two groups in terms of mortality, hospitalisation, adverse events and serious adverse events. CONCLUSIONS: Molnupiravir can accelerate the rehabilitation of COVID-19 patients, but it does not significantly reduce mortality and hospitalisation.

Homeopathic medicinal products for preventing and treating acute respiratory tract infections in children

Background: Acute respiratory tract infections (ARTIs) are common and may lead to complications. Most children experience between three and six ARTIs annually. Although most infections are self-limiting, symptoms can be distressing. Many treatments are used to control symptoms and shorten illness duration. Most treatments have minimal benefit and may lead to adverse events. Oral homeopathic medicinal products could play a role in childhood ARTI management if evidence for their effectiveness is established. This is an update of a review first published in 2018. Objectives: To assess the effectiveness and safety of oral homeopathic medicinal products compared with placebo or conventional therapy to prevent and treat ARTIs in children. Search methods: We searched CENTRAL (2022, Issue 3), including the Cochrane Acute Respiratory Infections Specialised Register, MEDLINE (1946 to 16 March 2022), Embase (2010 to 16 March 2022), CINAHL (1981 to 16 March 2022), AMED (1985 to 16 March 2022), CAMbase (searched 16 March 2022), and British Homeopathic Library (searched 26 June 2013- no longer operating). We also searched the WHO ICTRP and ClinicalTrials.gov (16 March 2022), checked references, and contacted study authors to identify additional studies. Selection criteria: We included double-blind randomised controlled trials (RCTs) or double-blind cluster-RCTs comparing oral homeopathy medicinal products with identical placebo or self-selected conventional treatments to prevent or treat ARTIs in children aged 0 to 16 years. Data collection and analysis: We used standard methodological procedures expected by Cochrane. Main results: In this 2022 update, we identified three new RCTs involving 251 children, for a total of 11 included RCTs with 1813 children receiving oral homeopathic medicinal products or a control treatment (placebo or conventional treatment) for ARTIs. All studies focused on upper respiratory tract infections (URTIs), with only one study including some lower respiratory tract infections (LRTIs). Six treatment studies examined the effect on URTI recovery, and five studies investigated the effect on preventing URTIs after one to four months of treatment. Two treatment and three prevention studies involved homeopaths individualising treatment. The other studies used predetermined, non-individualised treatments. All studies involved highly diluted homeopathic medicinal products, with dilutions ranging from 1 x 10-4 to 1 x 10-200. We identified several limitations to the included studies, in particular methodological inconsistencies and high attrition rates, failure to conduct intention-to-treat analysis, selective reporting, and apparent protocol deviations. We assessed three studies as at high risk of bias in at least one domain, and many studies had additional domains with unclear risk of bias. Four studies received funding from homeopathy manufacturers;one study support from a non-government organisation;two studies government support;one study was co-sponsored by a university;and three studies did not report funding support. Methodological inconsistencies and significant clinical and statistical heterogeneity precluded robust quantitative meta-analysis. Only four outcomes were common to more than one study and could be combined for analysis. Odds ratios (OR) were generally small with wide confidence intervals (CI), and the contributing studies found conflicting effects, so there was little certainty that the efficacy of the intervention could be ascertained. All studies assessed as at low risk of bias showed no benefit from oral homeopathic medicinal products, whilst trials at unclear or high risk of bias reported beneficial effects. For the comparison of individualised homeopathy versus placebo or usual care for the prevention of ARTIs, two trials reported on disease severity;due to heterogeneity the data were not combined, but neither study demonstrated a clinically significant difference. We combined data from two trials for the outcome need for antibiotics (OR 0.79, 95% CI 0.35 to 1.76;low-certainty evi

Six months follow-up study on health care workers on persistence of antibodies to SARS-CoV-2 after covishield vaccination

BACKGROUND: Efficacy of COVID vaccines has been evaluated in various studies. The interim analysis from four randomized controlled trials in UK, Brazil, and south Africa regarding efficacy of two doses of the vaccine was found to be 70.4% (95.8% CI 54.8-80.6). There is a limited data on follow-up Ab titer post vaccination. Hence, the current study is first of its kind with the objective to determine vaccine long term efficacy and its determinants. METHODS: Health Care Workers (HCW) from Apollo Multispeciality Hospitals, Kolkata who underwent Covishield vaccination from January 2021 to April 2021 were included in the study. Serological testing was done prior to first and second dose of vaccinations, and additionally around six months post second dose. RESULTS: Between January 2021 to April 2021, 2032 HCW, with predominant age of less than 30 years (44.83%) and male gender (61.96%) undergoing Covishield vaccination were enrolled. Antibodies were detected in 953 (46.9%) individuals prior to first dose, 1449 out of 1495 (96.9%) remained positive prior to second dose and 465 out of 504 (92.3%) HCW after 6 months and remaining 39 (7.7%) either had lost or never had antibodies in their blood. The mean +or- SD value of first, second and third antibodies were 2.35 +or- 3.10, 10.46 +or- 4.84 and 8.75 +or- 4.88 respectively. CONCLUSIONS: This study provides long observation period, covering the complete progress of the pandemic which provides a "real-life" picture of the antibody level dynamics over time, and after vaccination.

Effectiveness of atorvastatin in reducing inflammatory markers and hospitalization period in adults with COVID-19: a randomized clinical trial

Background and Objectives: Statins, which are primarily used for controlling blood cholesterol levels, have a well-known role in inhibiting the inflammatory process and reducing mortality rate of infectious diseases. This study aims to evaluate the effect of atorvastatin along with standard treatment protocol in hospitalized adults with COVID-19. Methods: This randomized controlled clinical trial was conducted on adults hospitalized due to COVID-19 infection at Shahid Beheshti Hospital in Qom, Iran from April to September 2020. They were randomly divided into groups of treatment (n=37, receiving atorvastatin 40 mg daily for 30 days plus standard treatment protocol) and control (n=37, receiving standard treatment protocol alone). The data were analyzed in SPSS v.22 software using chi-square, paired t-test, and ANOVA. P < 0.05 was statistically significant. Results: The CRP level in the atorvastatin-treated group decreased significantly such that there was a significant difference between the two groups after 30 days (P=0.01). There was no significant difference in Spo2 level on the discharge day. The length of hospitalization in the atorvastatin-treated group was significantly reduced compared to the control group (P < 0.05). Conclusion: The use of atorvastatin as an adjunctive treatment method, can significantly reduce the length of hospitalization and CRP level after 30 days in hospitalized patients.

Estimation and interpretation of vaccine efficacy in COVID-19 randomized clinical trials

Objectives: An exceptional effort by the scientific community has led to the development of multiple vaccines against COVID-19. Efficacy estimates for these vaccines have been widely communicated to the general public, but are nonetheless challenging to compare because they are based on phase 3 trials that differ in study design, definition of vaccine efficacy and the handling of cases arising shortly after vaccination. We investigate the impact of these choices on vaccine efficacy estimates, both theoretically and by re-analyzing the Janssen and Pfizer COVID-19 trial data under a uniform protocol. We moreover study the causal interpretation that can be assigned to per-protocol analyses typically performed in vaccine trials. Finally, we propose alternative estimands to measure the intrinsic vaccine efficacy in settings with delayed immune response. Methods: The data of the Janssen COVID-19 trials were recreated, based on the published Kaplan-Meier curves. An estimator for the alternative causal estimand was developed using a Structural Distribution Model. Results: In the data analyses, we observed rather large differences between intention-to-treat and per-protocol effect estimates. In contrast, the causal estimand and the different estimators used for per-protocol effects lead approximately to the same estimates. Conclusions: In these COVID-10 vaccine trials, per-protocol effects can be interpreted as the number of cases that can be avoided by vaccination, if the vaccine would immediately induce an immune response. However, it is unclear whether this interpretation also holds in other settings.

Effectiveness of tocilizumab in non-intubated cases with COVID-19: a systematic review and meta-analysis.

PURPOSE: Tocilizumab, a monoclonal IL-6 receptor blocker, is an effective agent for severe-to-critical cases of COVID-19; however, its target patients for the optimum use need to be detailed. We performed a systematic review and meta-analysis to define its effect among severely ill but non-intubated cases with COVID-19. METHODS: We searched PubMed, Scopus, Web of Science, MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), Medrxiv, and Biorxiv until February 13, 2022, for non-intubated cases, and included randomized-controlled trials (RCT) based on bias assessment. The primary outcomes were the requirement of invasive mechanical ventilation and mortality. Random effect and fixed-effect models were used. The heterogeneity was measured using the χ2 and I2 statistics, with χ2 p ≤ 0.05 and I2 ≥ 50% indicating the presence of significant heterogeneity. We registered the study to the International Prospective Register of Systematic Reviews (PROSPERO) with the registration number CRD42021232575. RESULTS: Among 261 articles, 11 RCTs were included. The pooled analysis of the 11 RCTs demonstrated that the rate of mortality was significantly lower in the tocilizumab group than in the control group (20.0% and 24.2%, OR: 0.84, 95% CI 0.73-0.96, and heterogeneity I2 = 0%. p = 0.82.). The mechanical ventilation rate was lower in the tocilizumab group than the control group (27% vs 35.2%, OR: 0.76, 95% CI 0.67-0.86, and heterogeneity I2 = 6%. p = 0.39). CONCLUSION: Among non-intubated severe COVID-19 cases, tocilizumab reduces the risk of invasive mechanical ventilation and mortality compared to standard-of-care treatment.

Effect of aqueous extract of violet on fever in patients with COVID-19: a randomized clinical trial

Background and purpose: Violet is a plant that has received interest in complementary medicine due to its anti-inflammatory, antipyretic, and antimicrobial effects. Fever is one of the major symptoms of COVID-19. This study was conducted to determine the effect of violet extract in the form of syrup on fever in patients with COVID-19. Materials and methods: In this randomized clinical trial, 52 patients with COVID-19 were studied in Intensive Care Unit in Amol Imam Khomeini Hospital (2021). In intervention group in addition to an injection of acetaminophen, 5 cc of violet extract syrup prepared from the aqueous extract of the plant was taken. The temperature was recorded after 30 and 60 minutes and four hours. The follow-up of the patients continued for three days and the temperature was recorded every six hours. Results: There was a significant difference between the intervention group (36.84..0.37) and control group (37.13..0.62) in mean temperature at second time in second day of follow-up (P=0.04). Also, the mean temperature was found to be significantly different between the two groups at 30 (P=0.001) and 60 minutes (P=0.05) after the intervention. At other groups, there was no significant difference between the intervention and control groups. Conclusion: The aqueous extract of violet plant in the form of syrup reduces fever in patients with COVID-19 causing no complication. Due to the ease of access to this herbal product, it can be used to prevent problems caused by fever.

The benefits of continuing patient and public involvement as part of a randomised controlled trial during the Covid-19 global pandemic

Patient and public involvement (PPI) in clinical research strengthens the quality and relevance of research, and has been crucial to ensure that researchers continue to investigate relevant and important topics during the global Covid-19 pandemic. The MICE (Mental Health Intervention for Children with Epilepsy) randomised controlled trial relies upon PPI to steer the direction and delivery of the trial, and the PPI Research Advisory Group (RAG) adapted to remote online meetings during the pandemic. This article first describes how the PPI RAG supported the research trial during the course of the pandemic, particularly with key trial stages of recruitment, retention and follow-up. It considers how the PPI tasks were adapted to ensure that they remained meaningful throughout this period, particularly for children and young people. Second, the article explores the acceptability of PPI in research using teleconferencing methods, via a co-produced survey of the PPI group members. Survey results indicated that, while participants valued face-to-face meetings, having remote PPI meetings was preferable to having nothing. There was some suggestion that teleconferencing platforms make it challenging for reserved members of the group, and for children, to contribute. Our findings emphasise the importance of continuing PPI even when circumstances are sub-optimal. We hope that our findings will contribute to the wider conversation about what makes PPI effective, particularly in a digital world. [ FROM AUTHOR] Copyright of Research for All is the property of UCL Press and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Comparative impact of repositioned anticancer therapies on non-cancer COVID-19 patient treatment: a systematic review and network meta-analysis of randomized controlled trials

Purpose: Coronavirus disease 2019 (COVID-19) has emerged as a serious threat to public health;anticancer-repositioning treatment strategy has been formulated to treat the disease. However, evidence supporting the efficacy and safety of repositioned anticancer treatment in treating COVID-19-infected non-cancer patients (CINPs) is limited. Therefore, this study analyzed published randomized controlled trials (RCTs) evaluating the impact of anticancer drugs compared to current standards of care (SOCs) on CINP treatment. Materials and methods: The PubMed and Embase databases were searched to identify eligible RCTs. Outcome measures included mortality, the use of mechanical ventilation (MV), and serious adverse events (SAEs). Results: 25 RCTs were reviewed in our study. Compared to SOCs, repositioned anticancer therapy for treating CINPs was associated with mortality reduction (odds ratio (OR) = 0.78, 95% confidence interval (CI) = 0.65 - 0.94, p = 0.01). Using the repositioned anticancer treatment exhibited statistically significant reduction, in both the number of CINPs using MV (OR = 0.67, 95% CI = 0.51 - 0.88, p = 0.004) and experiencing SAEs (OR = 0.79, 95% CI = 0.69 - 0.91, p = 0.0009). Conclusion: Conclusively, repositioned anticancer treatment was shown significant differences from SOCs in treating CINPs, which appears to be more associated with mortality, MV use, and SAE development reduction in CINPs.

Ethical issues in care research: an analysis

Research involving the residents of care homes is vital to improve their health and wellbeing. Such research can make a major contribution to the health and social challenges facing society, including dementia and ageing. However, research is less common in the care context than in health settings. Studies submitted to the Health Research Authority over a 3-year period for ethics review were analysed to identify ethical barriers to research. Just 0.5% of research studies that were submitted involved care homes. The most common subjects researched were residents' wellbeing, COVID-19 and care home processes and management. Analysis of the response of research ethics committees showed that the majority of questions or comments concerned the consent process, care and respect for the participants, and the social and scientific value of the planned research. There were a number of issues that were commonly raised by research ethics committees. In addition, the majority of studies involved adults who potentially lacked capacity. This work identifies the issues that are raised by research ethics committees and highlights specific ethical concerns about research in the care setting.

A pilot study on controlling Coronavirus disease 2019 (COVID-19) inflammation using melatonin supplement

No effective antiviral drugs and vaccines are available for the treatment of patients with severe coronavirus 2019 (COVID-19). Therefore, available, safe, and inexpensive drugs and supplements such as melatonin are among the proposed options for controlling inflammation. We did a randomized, single-blind study in Imam Khomeini Hospital between June 30, 2020, and August 5, 2020. Mild to moderate COVID-19 patients aged 25-65 years were eligible to enter the study based on chest CT scan, clinical symptoms, and physician diagnosis. The intervention group was prescribed 6 mg of oral melatonin for 2 weeks, which consumed half an hour before bedtime every night in low light conditions. Clinical symptoms and C-reactive protein (CRP) were measured before and after treatment in the melatonin received and control(regular medications)groups. Among screened patients with COVID-19, 14 patients were assigned to receive melatonin, and 17 patients were considered as controls. A significant difference (p=0.005) between CRP 1 and CRP 2 levels (before and after using melatonin) was found in the melatonin group while this difference (p=0.069) was not significant in the control group. Also, the percentage of recovery (based on symptoms) in patients who took melatonin was higher than that of patients in the control group (85.7%VS 47.1%). The result of this study confirmed the effectiveness of melatonin in mild to moderate outpatients with COVID-19. More clinical trials on elderly, diabetic, obese patients and severe cases are suggested in future studies.

Supplementation of Vitamin D and Mental Health in Adults with Respiratory System Diseases: A Systematic Review of Randomized Controlled Trials.

Vitamin D is indicated to be beneficial for the prevention and treatment of both respiratory health and mental health problems, while mental health issues are a common consequence of diseases of the respiratory system. The aim of the presented systematic review was to gather available evidence regarding the influence of the supplementation of vitamin D on mental health in adults with respiratory system diseases obtained within randomized controlled trials (RCTs). The systematic review was conducted on the basis of the PubMed and Web of Science databases in agreement with the guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), while being registered within the database of the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42020155779). A total of 8514 studies published before September 2021 were screened and 5 RCTs were included, which were assessed using the revised Cochrane risk-of-bias tool for randomized trials. Screening, inclusion, reporting, and assessment were conducted by two researchers independently. The studies focused on the assessment of patients with chronic obstructive pulmonary disease, but also increased susceptibility to respiratory tract infections, pulmonary tuberculosis, and bronchial asthma. The studies were conducted for various periods of time-from 2 months to a year-while the dose of vitamin D applied was also diverse-from 4000 IU applied daily, to 100,000 IU applied weekly, or monthly. The psychological measures applied within the studies allowed the assessment, mainly, of quality of life, but also well-being, and depression. For the majority of studies, some concerns regarding risk of bias were defined, resulting from the randomization process and selection of reported results; however, for one study, the risk was even defined as high. Within the included studies, three studies confirmed a beneficial effect of vitamin D (including those with a high risk of bias), but two studies did not confirm it. Taking into account the evidence gathered, in spite of a positive influence of vitamin D on mental health in individuals with increased susceptibility to respiratory tract infections and bronchial asthma, the conducted systematic review is not a strong confirmation of the beneficial effect of the supplementation of vitamin D on mental health in adults with respiratory system diseases.

De-implementing opioid prescribing in a dental group practice: Lessons learned.

BACKGROUND: Drug overdose has become a leading cause of accidental death in the United States. Between 2000 and 2015, the rate of deaths from drug overdoses increased 137%, including a 200% increase in the rate of overdose deaths involving opioids (including opioid pain relievers and heroin). Unnecessary opioid prescribing is one of the factors driving this epidemic. OBJECTIVES: The primary objective of this paper is to share lessons learned while conducting a randomized trial to de-implement opioids for post-extraction pain management utilizing clinical decision support (CDS) with and without patient education. The lessons learned from conducting this trial in a real-world setting can be applied to future dissemination and implementation oral health research. METHODS: The sources informing lessons learned were generated from qualitative interviews conducted with 20 of the forty-nine dental providers involved in the study following the implementation phase of the trial. Ongoing policy, social and environmental factors were tracked throughout the study. RESULTS: Dental providers in the trial identified the impact of training that involved health professionals sharing information about the personal impact of pain and opioid use. Additionally, they found utility in being presented with a dashboard detailing their prescribing patterns related to other dentists. For the 30 general dentists with access to the CDS, use of its portal varied widely, with most using it 10%-49% of the time related to extractions. CONCLUSIONS: In the context of a downward trend in opioid prescribing and considering the influence of the COVID pandemic during the trial, dental providers indicated benefit in training about negative personal impacts of prescribing opioids, and personally relevant feedback about their prescribing patterns. Only modest use of the CDS was realized. Implementation of this trial was impacted by governmental and health system policies and the COVID pandemic, prompt the consideration of implications regarding continuing ways to limit opioid prescribing among dental providers.

Disaster preparedness in healthcare professionals amid COVID-19 and beyond: A systematic review of randomized controlled trials.

BACKGROUND: Disasters like COVID-19 are oftentimes inevitable, which makes disaster preparedness indispensable to global health and social stability. However, there is a dearth of understanding of how well healthcare professionals, who often have to work at the epicenter of disasters as they evolve, are trained to be sufficiently prepared for these crises. To this end, this study aims to examine the characteristics and effectiveness of existing interventions that aim to improve healthcare professionals' disaster preparedness. METHODS: We searched RCTs that aim to improve healthcare professionals' disaster preparedness in databases including PubMed, PsycINFO, CINAHL and Scopus. Results were screened against the eligibility criteria. The review was registered with PROSPERO (CRD42020192517) and conducted following the PRISMA guidelines. RESULTS: A total of 7382 articles were screened for eligibility, among which, 27 RCTs, incorporating 35,145, met the inclusion criteria. Review results show that most of the eligible RCTs were conducted in high-income countries. Only two RCTs were developed in disaster contexts that share similarities with COVID-19. Most of the interventions did not address critical disaster coping abilities, such as how can healthcare professionals protect or improve their personal or the general public's mental health amid pandemics. Furthermore, almost half of the disaster preparedness RCTs failed to generate statistically significant outcomes. CONCLUSIONS: Albeit inevitable, disasters are preventable. Our study results underscore the imperative of designing and developing effective and comprehensive interventions that could boost healthcare professionals' disaster preparedness, so that these frontline workers can better protect personal and public health amid global crises like COVID-19.

Electronic informed consent: effects on enrolment, practical and economic benefits, challenges, and drawbacks-a systematic review of studies within randomized controlled trials.

BACKGROUND: Enrolment is one of the most challenging aspects of conducting clinical trials, preceded by the process of informed consent (IC). Different strategies to improve recruitment in clinical trials have been used, including electronic IC. During COVID-19 pandemic, barriers to enrolment have been evident. Although digital technologies were acknowledged as the future of clinical research and potential advantages were shown for recruitment, electronic informed consent (e-IC) has not yet been globally adopted. The purpose of this review is to investigate the effect of using e-IC on enrolment, practical and economic benefits, challenges, and drawbacks when compared to traditional informed consent, through a systematic review. METHODS: Embase, Global Health Library, Medline, and The Cochrane Library databases were searched. No limit was set for publication date, age, sex, or study design. We included all studies within a randomized controlled trial (RCT), published in English, Chinese or Spanish, evaluating the electronic consent process used in the parent RCT. Studies were included if any of the three components ((i) information provision, (ii) participant's comprehension, (iii) signature) of the IC process was designed as electronic, whether administered remotely or face-to-face. The primary outcome was the rate of enrolment to the parent trial. Secondary outcomes were summarized according to the various findings reported on the use of electronic consent. RESULTS: From a total of 9069 titles, 12 studies were included in the final analysis with a total of 8864 participants. Five studies of high heterogeneity and risk of bias showed mixed results on the efficacy of e-IC on enrolment. Data of included studies suggested e-IC could improve comprehension and recall of study-related information. Meta-analysis could not be conducted due to different study designs and outcome measures and the predominantly qualitative findings. CONCLUSION: Few published studies have investigated the impact of e-IC on enrolment and findings were mixed. e-IC may improve participant's comprehension and recall of information. High-quality studies are needed to evaluate the potential benefit of e-IC to increase clinical trial enrolment. TRIAL REGISTRATION: PROSPERO CRD42021231035 . Registration date: 19-Feb-2021.

Evidence-Based Medicine in Otolaryngology Part 14: Falsehood and Bias.

OBJECTIVE: Falsehood and bias can have tangible effects, whether related to the "hoax" of Corona virus disease/COVID-19 or the impact of personal protective equipment in city-wide news. The spread of false information requires the diversion of time and resources into rebolstering the truth. Our objective is thus to elucidate types of bias that may influence our daily work, along with ways to mitigate them. DATA SOURCES: Publications are included which delineate specific aspects of bias or address how to preempt, mitigate, or correct bias, whether conscious or unconscious. REVIEW METHODS: We discuss: (1) the background and rationale for proactively considering potential sources of bias, (2) relevant definitions and concepts, (3) potential means to limit effects of inaccurate data sources, and (4) evolving frontiers in the management of bias. In doing so, we review epidemiological concepts and susceptibility to bias within study designs, including database studies, observational studies, randomized controlled trials (RCTs), systematic reviews, and meta-analyses. We additionally discuss concepts such as the difference between disinformation and misinformation, differential or nondifferential misclassification, bias toward a null result, and unconscious bias, among others. CONCLUSION: We have the means to mitigate sources of potential bias in database studies, observational studies, RCTs, and systematic reviews, beginning with education and awareness. IMPLICATIONS FOR PRACTICE: False information may spread faster than true information, so it is beneficial to understand potential sources of falsehood we face, in order to safeguard our daily impressions and decisions. Awareness of potential sources of falsehood and bias forms the foundation for accuracy in our everyday work.