Population, Intervention, Comparison, Outcome Research Articles

ANTI-INFLAMMATORY POTENTIAL OF ALOE VERA IN ORAL MUCOSITIS THERAPY: SYSTEMATIC REVIEW

This review aims to analyse the potency of Aloe vera for Oral Mucositis (OM) therapy. Articles searched using the keywords “Oral Mucositis” AND “Aloe vera”, conducted through PubMed, ScienceDirect, and Cochrane Library databases, and adapted to the PICO (Population, Intervention, Comparison, Outcome) framework. The inclusion criteria for articles were: Randomized Controlled Trial (RCT) study design; in English; full paper available; published in the range between 2011-2021 and with low risk of bias. RoB-tools JADAD Oxford Quality Scoring System was used. This paper writing refers to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines. A total of 5 (five) articles met the criteria for a qualitative review and all showed a high range of quality articles. It was found that both Aloe vera solution 70% and Aloe vera gel 10% showed a reduction of radiotherapy or chemotherapy-induced oral mucositis grade. Aloe vera mouthwash has an equal anti-inflammation effect compare to benzydamine on the patient with radiotherapy-induced oral mucositis, whereas the use of other formula containing Aloe vera with other herbal materials did not show an anti-inflammatory effect. Drug formulation containing Aloe vera can be used as an alternative therapy in the management of Oral Mucositis (OM) with anti-inflammatory potency that can reduce pain and the severity of oral mucositis.

SCAI Guidelines for the Management of Patent Foramen Ovale.

Patent foramen ovale (PFO) is a vestigial congenital cardiovascular structure present in around 25% of adults. In most cases, PFO is entirely benign and requires no treatment. However, it may cause serious complications under certain circumstances. These evidence-based guidelines from the Society for Cardiovascular Angiography and Interventions (SCAI) aim to support patients, clinicians, and other stakeholders in decisions about management of PFO. SCAI convened a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The Evidence Foundation, a registered 501(c)(3) nonprofit organization, provided methodological support for the guideline-development process. Following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, the guideline panel formulated and prioritized clinical questions in population, intervention, comparison, outcome (PICO) format. A separate technical review team of clinical and methodological experts conducted systematic reviews of the evidence, synthesized data, and graded the certainty of the evidence across outcomes. The guideline panel then reconvened to formulate recommendations and supporting remarks informed by the results of the technical review and additional contextual factors described in the GRADE evidence-to-decision framework. The panel agreed on 13 recommendations to address variations on 5 clinical scenarios. Key recommendations address patient selection for PFO closure in the prevention of recurrent PFO-associated stroke, including populations not commonly included in randomized studies, and scenarios where the PFO closure might serve a role in the prevention of other outcomes such as migraine headaches and decompression illness. The panel has also identified future research priorities to advance the field.

Theory of planned behaviour-based interventions in chronic diseases among low health-literacy population: protocol for a systematic review

BackgroundHealth behaviour can change outcomes in both healthy and unhealthy populations and are particularly useful in promoting compliance to treatment and maintaining fidelity to care seeking and follow-up options in chronic diseases. Interventions to change health behaviour based on psychological theory are more often successful than those without any underlying theory. The theory of planned behaviour (TPB) is one such psychological theory which had been found to predict human behaviour with respect to disease prevention and when applied to interventions can change the outcomes of diseases. Most of the research evidence of TPB-based interventions have been from developed world. Evidence is required whether TPB-based interventions can be applied and works in low-resource, low health-literacy settings of low- and middle-income countries (LMICs).MethodsThe protocol has been developed as per PRISMA-P guidelines and incorporates PICO (population, intervention, comparison, outcomes) framework for describing the methodology. Population above 18 years of age and having any chronic disease (as defined for this systematic review) will be selected, while any health or educational intervention based on constructs of TPB will be included. Comparison will be with non-TPB-based interventions or treatment as usual without any intervention, and the primary outcome will be the behaviour change effected by the TPB-based intervention. Intervention studies will be considered, and relevant databases like MEDLINE, Embase, Cochrane Library and ProQuest will be explored. Data extraction will done in a standardised form, and risk-of-bias assessment will be done using the Cochrane Collaboration’s tools for such assessment. Narrative synthesis of the selected studies will be done to draw the conclusions, and meta-analysis will be done to calculate the effect estimates with I-squared statistics to describe the heterogeneity.DiscussionThis systematic review will provide new evidence on fidelity and effectiveness of the TPB-based interventions among chronic disease patients from low health literacy, resource-poor background. It will inform of how to plan and use such interventions to change health behaviour in chronic disease patients, particularly in LMIC settings.Systematic review registrationPROSPERO CRD42018104890.

Prevalence, socio-demographics and service use determinants associated with disclosure of HIV/AIDS status to infected children: a systematic review and meta-analysis by 1985–2021

BackgroundHuman immunodeficiency virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) is a public health issue of global importance. To our knowledge, no previous meta-analysis documenting the prevalence, socio-demographic, and service use determinants associated with HIV/AIDS disclosure to infected children has been conducted. The present study aimed to determine the prevalence, socio-demographics and service use determinants associated with the disclosure of HIV/AIDS status to infected children.MethodsStudies in English published between 01 January 1985 and 01 November 2021, and available on PubMed, Scopus, Web of Science, and Cochrane electronic databases were searched. After reviewing for study duplicates, the full-text of selected articles were assessed for eligibility using Population, Intervention, Comparator, Outcomes (PICO) criteria. We used fixed and random-effects meta-analysis models to estimate the pooled prevalence, pooled odds ratio (OR), and 95% confidence intervals.ResultsAfter article duplicates were excluded, assessments of abstracts were completed, and full-text papers evaluated, 37 studies were included in this meta-analysis. The prevalence of the disclosure of HIV status to children was measured to be 41% in this research. The odds that a child of 10 years and older is informed that they are HIV-positive is 3.01 time the odds that younger children are informed. Those children who had primary or lower schooling level were 2.41 times more likely to be informed of their HIV-positive status than children with higher levels of schooling. Children who had a non-biological parents were 3.17 times more likely to have been disclose being HIV-positive; social support (OR = 8.29, 95%CI = 2.34, 29.42), children who had higher levels of social supports were 8.29 times more likely to disclose HIV-positive; the primary educational level of caregivers (OR = 2.03, 95%CI = 1.43, 2.89), respondents who had caregivers with primary education level were 2.03 times more likely to disclose HIV-positive; antiretroviral treatment (ART) adherence (OR = 2.59, 95%CI = 1.96, 3.42), participants who adhered to ART were 2.59 times more likely to disclose HIV-positive and hospital follow-up (OR = 2.82, 95%CI = 1.85, 4.29), those who had hospital follow-up were 2.82 times more likely to disclose HIV-positive; were all significantly associated with the disclosure of HIV/AIDS status to infected children.ConclusionSuch data are of importance for healthcare pediatrics HIV care professionals. Facilitating HIV diagnosis and disclosure to the infected children and ensuring access to HIV treatment will likely prevent secondary HIV transmission. Healthcare professionals are expected to provide age-appropriate counseling services to this population.

European Stroke Organisation guidelines on treatment of patients with intracranial atherosclerotic disease.

The aim of the present European Stroke Organisation guideline is to provide clinically useful evidence-based recommendations on the management of patients with intracranial atherosclerotic disease (ICAD). The guidelines were prepared following the Standard Operational Procedure of the European Stroke Organisation guidelines and according to GRADE methodology. ICAD represents a major cause of ischemic stroke worldwide, and patients affected by this condition are exposed to a high risk for future strokes and other major cardiovascular events, despite best medical therapy available. We identified 11 relevant clinical problems affecting ICAD patients and formulated the corresponding Population Intervention Comparator Outcomes (PICO) questions. The first two questions refer to the asymptomatic stage of the disease, which is being increasingly detected thanks to the routine use of noninvasive vascular imaging. We were not able to provide evidence-based recommendations regarding the optimal detection strategy and management of asymptomatic ICAD, and further research in the field is encouraged as subclinical ICAD may represent a big opportunity to improve primary stroke prevention. The second block of PICOs (3-5) is dedicated to the management of acute large vessel occlusion (LVO) ischemic stroke caused by ICAD, a clinical presentation of this disease that is becoming increasingly relevant and problematic, since it is associated with more refractory endovascular reperfusion procedures. An operational definition of probable ICAD-related LVO is proposed in the guideline. Despite the challenging context, no dedicated randomized clinical trials (RCTs) were identified, and therefore the guideline can only provide with suggestions derived from observational studies and our expert consensus, such as the escalated use of glycoprotein IIb-IIIa inhibitors and angioplasty/stenting in cases of refractory thrombectomies due to underlying ICAD. The last block of PICOs is devoted to the secondary prevention of patients with symptomatic ICAD. Moderate-level evidence was found to recommend against the use of oral anticoagulation as preferred antithrombotic drug, in favor of antiplatelets. Low-level evidence based our recommendation in favor of double antiplatelet as the antithrombotic treatment of choice in symptomatic ICAD patients, which we suggest to maintain during 90 days as per our expert consensus. Endovascular therapy with intracranial angioplasty and or stenting is not recommended as a treatment of first choice in high-grade symptomatic ICAD (moderate-level evidence). Regarding neurosurgical interventions, the available evidence does not support their use as front line therapies in patients with high-grade ICAD. There is not enough evidence as to provide any specific recommendation regarding the use of remote ischemic conditioning in ICAD patients, and further RCTs are needed to shed light on the utility of this promising therapy. Finally, we dedicate the last PICO to the importance of aggressive vascular risk factor management in ICAD, although the evidence derived from RCTs specifically addressing this question is still scarce.

Guidelines on the management of abdominal aortic aneurysms: updates from the Italian Society of Vascular and Endovascular Surgery (SICVE)

The objective of these Guidelines was to revise and update the previous 2016 Italian Guidelines on Abdominal Aortic Aneurysm Disease, in accordance with the National Guidelines System (SNLG), to guide every practitioner toward the most correct management pathway for this pathology. The methodology applied in this update was the GRADE-SIGN version methodology, following the instructions of the AGREE quality of reporting checklist as well. The first methodological step was the formulation of clinical questions structured according to the PICO (Population, Intervention, Comparison, Outcome) model according to which the Recommendations were issued. Then, systematic reviews of the Literature were carried out for each PICO question or for homogeneous groups of questions, followed by the selection of the articles and the assessment of the methodological quality for each of them using qualitative checklists. Finally, a Considered Judgment form was filled in for each clinical question, in which the features of the evidence as a whole are assessed to establish the transition from the level of evidence to the direction and strength of the recommendations. These guidelines outline the correct management of patients with abdominal aortic aneurysm in terms of screening and surveillance. Medical management and indication for surgery are discussed, as well as preoperative assessment regarding patients' background and surgical risk evaluation. Once the indication for surgery has been established, the options for traditional open and endovascular surgery are described and compared, focusing specifically on patients with ruptured abdominal aortic aneurysms as well. Finally, indications for early and late postoperative follow-up are explained. The most recent evidence in the Literature has been able to confirm and possibly modify the previous recommendations updating them, likewise to propose new recommendations on prospectively relevant topics.

Clinical Practice Guideline: Early Mobilization and Rehabilitation of Critically Ill Burn Patients.

This Clinical Practice Guideline addresses early mobilization and rehabilitation (EMR) of critically ill adult burn patients in an intensive care unit (ICU) setting. We defined EMR as any systematic or protocolized intervention that could include muscle activation, active exercises in bed, active resistance exercises, active side-to-side turning, or mobilization to sitting at the bedside, standing, or walking, including mobilization using assistance with hoists or tilt tables, which was initiated within at least 14 days of injury, while the patient was still in an ICU setting. After developing relevant PICO (Population, Intervention, Comparator, Outcomes) questions, a comprehensive literature search was conducted with the help of a professional medical librarian. Available literature was reviewed and systematically evaluated. Recommendations were formulated through the consensus of a multidisciplinary committee, which included burn nurses, physicians, and rehabilitation therapists, based on the available scientific evidence. No recommendation could be formed on the use of EMR to reduce the duration of mechanical ventilation in the burn ICU, but we conditionally recommend the use of EMR to reduce ICU-acquired weakness in critically ill burn patients. No recommendation could be made regarding EMR's effects on the development of hospital-acquired pressure injuries or disruption or damage to the skin grafts and skin substitutes. We conditionally recommend the use of EMR to reduce delirium in critically ill burn patients in the ICU.

Rehabilitation Definition for Research Purposes. A Global Stakeholders’ Initiative by Cochrane Rehabilitation

Since its foundation, Cochrane Rehabilitation has faced challenges with rehabilitation definitions because existing definitions did not indicate what rehabilitation includes and what it excludes. We aimed to develop a comprehensive and shared rehabilitation definition for research purposes to: (1) support the conduct of primary studies and systematic reviews, and (2) identify relevant systematic reviews for knowledge translation purposes. We performed a multimodal study including seven preliminary research and discussion papers, four Consensus Meetings, and three Delphi rounds with 80 rehabilitation stakeholders. The Delphi Study aimed to obtain agreement, refine and complete the items composing the definition and meanings of rehabilitation. These stakeholders covered 5 continents, representing 11 global and continental rehabilitation organizations, 11 scientific journals, 4 Cochrane Networks, and 3 Cochrane Groups, and included invited experts, and representatives of low middle-income countries and consumers. We had a 70% to 82.5% response rate to the three Delphi rounds, during which participants responded to all items (100%) and provided relevant comments (range 5.5–50% per item). This participation led to several refinements to the rehabilitation definition through three preliminary versions, and the final items reached an agreement between 88.9% and 100%. We structured the definition using the PICO (Population, Intervention, Comparison, Outcome) framework. We concluded that “In a health care context,” rehabilitation is defined as a “multimodal, person-centered, collaborative process” (Intervention-general), including interventions targeting a person’s “capacity (by addressing body structures, functions, and activities/participation) and/or contextual factors related to performance” (Intervention-specific) with the goal of “optimizing” the “functioning” (Outcome) of “persons with health conditions currently experiencing disability or likely to experience disability, or persons with disability” (Population). Rehabilitation requires that all the items of the definition are satisfied. We defined a “rehabilitation intervention” as “any intervention provided within the rehabilitation process.” We developed a rehabilitation definition for research purposes achieving a broad agreement with global stakeholders. This definition provides explicit criteria to define rehabilitation. Using the proposed definition will improve rehabilitation research by standardizing the description of interventions. Our definition may require revision in the future, as further research enhances understanding and communication of the essence and complexity of rehabilitation.

Rehabilitation Definition for Research Purposes: A Global Stakeholders' Initiative by Cochrane Rehabilitation.

ObjectiveSince its foundation, Cochrane Rehabilitation has faced challenges with rehabilitation definitions because existing definitions did not indicate what rehabilitation includes and what it excludes. We aimed to develop a comprehensive and shared rehabilitation definition for research purposes to: (1) support the conduct of primary studies and systematic reviews and (2) identify relevant systematic reviews for knowledge translation purposes.DesignWe performed a multimodal study including seven preliminary research and discussion papers, four Consensus Meetings, and three Delphi rounds with 80 rehabilitation stakeholders. The Delphi Study aimed to obtain agreement and refine and complete the items composing the definition and meanings of rehabilitation. These stakeholders covered 5 continents, representing 11 global and continental rehabilitation organizations, 11 scientific journals, 4 Cochrane Networks, and 3 Cochrane Groups and included invited experts and representatives of low middle-income countries and consumers.ResultsWe had a 70% to 82.5% response rate to the three Delphi rounds, during which participants responded to all items (100%) and provided relevant comments (range, 5.5%–50% per item). This participation led to several refinements to the rehabilitation definition through three preliminary versions, and the final items reached an agreement between 88.9% and 100%. We structured the definition using the PICO (Population, Intervention, Comparison, Outcome) framework. We concluded that “In a healthcare context,” rehabilitation is defined as a “multimodal, person-centered, collaborative process” (Intervention-general), including interventions targeting a person’s “capacity (by addressing body structures, functions, and activities/participation) and/or contextual factors related to performance” (Intervention-specific) with the goal of “optimizing” the “functioning” (Outcome) of “persons with health conditions currently experiencing disability or likely to experience disability, or persons with disability” (Population). Rehabilitation requires that all the items of the definition are satisfied. We defined a “rehabilitation intervention” as “any intervention provided within the rehabilitation process.”ConclusionsWe developed a rehabilitation definition for research purposes achieving a broad agreement with global stakeholders. This definition provides explicit criteria to define rehabilitation. Using the proposed definition will improve rehabilitation research by standardizing the description of interventions. Our definition may require revision in the future, as further research enhances understanding and communication of the essence and complexity of rehabilitation.

A nine‐step pathway to conduct an umbrella review of literature

A nine‐step pathway to conduct an umbrella review of literature

Comparison of the Effect of Glycemic Control on the Incidence of Fetal Macrosomia and Large for Gestational Age in Gestational Diabetes Mellitus Patients; A Systematic Review

Background: Gestational diabetes mellitus (GDM) can be managed with blood glucose control management, which includes a healthy lifestyle, insulin therapy, and oral anti-diabetic drug (OAD) medications when needed. Sub-optimally or poorly managed GD Mmay lead to arisk of complications, one of which is an abnormal growth in the fetus. This study aimed to compare the effect of blood glucose control management on the incidence of fetal macrosomia and large for gestational age (LGA) births in patients with GDM. Methods: This systematic review study obtained data from formerly published studies from the Science Direct database. The article search method used the characteristics of PICO (Population, Intervention, Comparison, Outcome) and compiled using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) method. Conclusion: The use of medical nutrition therapy (MNT) and exercise in the therapeutic regimen, as well as routine monitoring of glycemic levels are very important to control the patient’s glycemic level. The use of metformin can increase the success of therapy due to reduced levels of LGA and macrosomia in GDM patients

Systematic Reviews in Medical Education.

Systematic Reviews in Medical Education.

Does the use of alcohol mouthwash increase the risk of developing oral cancer?

Design Systematic review.Case selection This study had a focused research format in terms of PICO (Population, Intervention, Comparison, Outcomes). There were no age, gender or medical conditions which restricted or excluded patients from the inclusion criteria. The intervention was the use of alcohol-based mouthwashes in comparison to the control group where no mouthwash was used. A literature search was carried out utilising three electronic databases including PubMed, Scopus and Cochrane Library. The papers included for analysis within this review were all published from 2006 onwards and animal studies, case series and case reports were excluded.Data analysis The qualitative analysis included 43,499 participants from eight papers which included two meta-analyses, one clinical trial, three case-control studies and two cohort studies, all of which fulfilled the inclusion criteria. Data were analysed by two independent reviewers who initially screened the articles and removed duplications before a second round of in-depth evaluation was conducted. A third reviewer was also included to act impartially to resolve any disagreements and reduce bias within the study. Risk of bias within studies was assessed utilising the Newcastle-Ottawa Scale (NOS) which provided a uniform approach between the reviewers. A score of 6 or greater was associated with a low level of bias.Results The primary outcome parameter measured was acetaldehyde levels in saliva and the secondary outcome factor was the risk of developing an oral cancer. The results from this review concluded that the relationship between the use of alcohol mouthwash and cancer risk is complex and influenced by multiple variables. Factors which may influence the risk of developing an oral cancer from the use of alcohol mouthwash include increased frequency of rinsing (more than three times daily), total duration of mouthwash use (>35 years), poor oral hygiene and presence of other risk factors (for example, smoking and alcohol intake).Conclusions The use of alcohol-containing mouthwashes alone (when no other risk factors are present) does not increase the risk of developing an oral cancer or lead to increased salivary acetaldehyde. However, where other risk factors for oral cancer are present, the use of an alcohol-based mouthwash may further increase this risk.

Treatment of Provoked Vulvodynia: A Systematic Review

BackgroundTreatment recommendations for provoked vulvodynia (PVD) are based on clinical experiences and there is a need for systematically summarizing the controlled trials in this field. AimTo provide an overview of randomized controlled trials and non-randomized studies of intervention for PVD, and to assess the certainty of the scientific evidence, in order to advance treatment guidelines. Data SourcesThe search was conducted in CINAHL (EBSCO), Cochrane Library, Embase (Embase.com), Ovid MEDLINE, PsycINFO (EBSCO) and Scopus. Databases were searched from January 1, 1990 to January 29, 2021. Study Eligibility CriteriaPopulation: Premenopausal women with PVD. Interventions: Pharmacological, surgical, psychosocial and physiotherapy, either alone or as combined/team-based interventions. Control: No treatment, waiting-list, placebo or other defined treatment. Outcomes: Pain during intercourse, pain upon pressure or touch of the vaginal opening, sexual function/satisfaction, quality of life, psychological distress, adverse events and complications. Study design: Randomized controlled trials and non-randomized studies of interventions with a control group. Study Appraisal and Synthesis Methods2 reviewers independently screened citations for eligibility and assessed relevant studies for risk of bias using established tools. The results from each intervention were summarized. Studies were synthesized using a narrative approach, as meta-analyses were not considered appropriate. For each outcome, we assessed the certainty of evidence using grading of recommendations assessment, development, and evaluation (GRADE). ResultsMost results of the evaluated studies in this systematic review were found to have very low certainty of evidence, which means that we are unable to draw any conclusions about effects of the interventions. Multimodal physiotherapy compared with lidocaine treatment was the only intervention with some evidential support (low certainty of evidence for significant treatment effects favoring physiotherapy). It was not possible to perform meta-analyses due to a heterogeneity in interventions and comparisons. In addition, there was a heterogeneity in outcome measures, which underlines the need to establish joint core outcome sets. Clinical ImplicationsOur result underscores the need of stringent trials and defined core outcome sets for PVD. Strength and LimitationsStandard procedures for systematic reviews and the Population Intervention Comparison Outcome model for clinical questions were used. The strict eligibility criteria resulted in limited number of studies which might have resulted in a loss of important information. ConclusionThis systematic review underlines the need for more methodologically stringent trials on interventions for PVD, particularly for multimodal treatments approaches. For future research, there is a demand for joint core outcome sets.Bohm-Starke N, Ramsay KW, Lytsy P, et al. Treatment of Provoked Vulvodynia: A Systematic Review. J Sex Med 2022;19:789–808.

Updates from Important Trials in Cardiology of 2021 (January – June)

Critical appraisal of scientific publications is an important skill that must be acquired by the contemporary cardiologists. The preliminary step to a good critical appraisal is a sound understanding of the important aspects of a trial. In this issue of the Ibrahim Cardiac Medical Journal’s “Journal Scan”, we are first providing a brief summary of late-breaking randomised controlled trials published and presented at American College of Cardiology (ACC) Scientific Sessions 2021, and EuroPCR 2021, both of which were held virtually. We look at the important points to be derived from both potentially practice-changing trials, as well as key neutral trials of relevance in the above-mentioned meetings. In keeping with a critical appraisal format, each trial is introduced with its background and aims, PICO (Population, Intervention, Comparator, Outcomes) Criteria, main results and concluding remarks. Ibrahim Card Med J 2021; 11 (1): 86-95

TERAPI SPIRITUAL TERHADAP KECEMASAN DAN DEPRESI PADA PASIEN HEMODIALISIS : LITERATUR REVIEW

In the end-stage renal disease of CKD, the patients should be hemodialysis to stabilize the state of the kidney function. Increased psychological problems such as anxiety and depression resulting from CKD complications and the consequences of hemodialysis programs performed on patients. It is important for nurses to provide psychological support to patients. The application of complementary therapies such as spiritual therapy is essential. The purpose of this study was to explore various forms of spiritual therapy in hemodialysis for anxiety and depression. This study used electronic database were identified from MEDLINE, CINAHL, Proquest, and GARUDA. The criteria of the paper in this study are : articles published at 2012 – 2020, full text, the article using English or Bahasa Indonesia, and the method of study using experimental study. We extracted 6 intervention studies and critical analyzes used PICO (Population, Intervention, Comparator, Outcome) method. After applying spiritual therapy, several studies resulted in average scores of anxiety and depression that decreased in the intervention group, including Self Paced Therapy, Prayer, Dhikr, Murotal Holy Quran and Spiritual Counseling. In addition, this therapy also has a positive impact on some aspects of the patient's life include the physical and social relationships. Based on the analysis of the results some studies on CKD patients with hemodialysis therapy for anxiety and depression experienced the results obtained that spiritual therapy like include self-paced, prayer and dhikr therapy, and spiritual counselling can decrease anxiety and depression.

ESCMID COVID-19 guidelines: diagnostic testing for SARS-CoV-2

ScopeThe objective of these guidelines is to identify the most appropriate diagnostic test and/or diagnostic approach for SARS-CoV-2. The recommendations are intended to provide guidance to clinicians, clinical microbiologists, other health care personnel, and decision makers. MethodsAn ESCMID COVID-19 guidelines task force was established by the ESCMID Executive Committee. A small group was established, half appointed by the chair and the remaining selected with an open call. Each panel met virtually once a week. For all decisions, a simple majority vote was used. A list of clinical questions using the PICO (population, intervention, comparison, outcome) format was developed at the beginning of the process. For each PICO, two panel members performed a literature search focusing on systematic reviews, with a third panellist involved in case of inconsistent results. Quality of evidence assessment was based on the GRADE-ADOLOPMENT (Grading of Recommendations Assessment, Development and Evaluation - adoption, adaptation, and de novo development of recommendations) approach. RecommendationsA total of 43 PICO questions were selected that involve the following types of populations: (a) patients with signs and symptoms of COVID-19; (b) travellers, healthcare workers, and other individuals at risk for exposure to SARS-CoV-2; (c) asymptomatic individuals, and (d) close contacts of patients infected with SARS-CoV-2. The type of diagnostic test (commercial rapid nucleic acid amplification tests and rapid antigen detection), biomaterial, time since onset of symptoms/contact with an infectious case, age, disease severity, and risk of developing severe disease are also taken into consideration.

European Stroke Organisation - European Society for Minimally Invasive Neurological Therapy expedited recommendation on indication for intravenous thrombolysis before mechanical thrombectomy in patients with acute ischaemic stroke and anterior circulation large vessel occlusion.

Six randomized controlled clinical trials have assessed whether mechanical thrombectomy (MT) alone is non-inferior to intravenous thrombolysis (IVT) plus MT within 4.5 hours of symptom onset in patients with anterior circulation large vessel occlusion (LVO) ischaemic stroke and no contraindication to IVT. An expedited recommendation process was initiated by the European Stroke Organisation (ESO) and conducted with the European Society of Minimally Invasive Neurological Therapy (ESMINT) according to ESO standard operating procedure based on the GRADE system. We identified two relevant Population, Intervention, Comparator, Outcome (PICO) questions, performed systematic reviews and meta-analyses of the literature, assessed the quality of the available evidence and wrote evidence-based recommendations. Expert opinion was provided if insufficient evidence was available to provide recommendations based on the GRADE approach. For stroke patients with anterior circulation LVO directly admitted to a MT-capable centre ('mothership') within 4.5 hours of symptom onset and eligible for both treatments, we recommend IVT plus MT over MT alone (moderate evidence, strong recommendation). MT should not prevent the initiation of IVT, nor should IVT delay MT. In stroke patients with anterior circulation LVO admitted to a centre without MT facilities and eligible for IVT ≤4.5 hrs and MT, we recommend IVT followed by rapid transfer to a MT capable-centre ('drip-and-ship') in preference to omitting IVT (low evidence, strong recommendation). Expert consensus statements on ischaemic stroke on awakening from sleep are also provided. Patients with anterior circulation LVO stroke should receive IVT in addition to MT if they have no contraindications to either treatment.

ESCMID guidelines on testing for SARS-CoV-2 in asymptomatic individuals to prevent transmission in the health care setting

ScopeThis guideline addresses the indications for direct testing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in asymptomatic individuals in health care facilities, with the aim to prevent SARS-CoV-2 transmissions in these settings. The benefit of testing asymptomatic individuals to create a safe environment for patients and health care workers must be weighed against potential unintended consequences, including delaying necessary treatments owing to false positive results and lower quality of care owing to strict isolation measures. MethodsA total of nine PICOs (population, intervention, comparison, outcome) on the topic of testing asymptomatic individuals was selected by the panel members. Subsequently, a literature search for existing guidelines and systematic reviews was performed on PubMed, Epistemonikos, and RecMap using relevant filters available in each database. Data on article/recommendation type, setting, target population, intervention, and quality of the evidence were extracted. Credibility of the systematic reviews was evaluated using the AMSTAR tool, and level of agreement with available recommendation was evaluated with the AGREE II score. Because the evidence available from systematic reviews was deemed insufficiently updated to formulate relevant recommendations, an additional search targeting relevant guidance documents from major public health institutions and original studies was performed. Provisional recommendations were discussed via web conferences until agreement was reached, and final recommendations were formulated according to the GRADE approach. RecommendationsRecommendations were formulated regarding systematic testing in asymptomatic individuals upon admission to a health care setting, during hospital stay, before elective procedures, and before scheduled nonsurgical procedures. Moreover, recommendations regarding testing of asymptomatic visitors, personal caregivers, and health care workers in health care facilities were presented. Recommendations also were given on contact tracing in asymptomatic patients or health care workers and the possibility of a negative screening test to shorten the quarantine period. Furthermore, if applicable, recommendations were specified to transmission rate and vaccination coverage.

Impact of Varicocele Repair on Semen Parameters in Infertile Men: A Systematic Review and Meta-Analysis.

Despite the significant role of varicocele in the pathogenesis of male infertility, the impact of varicocele repair (VR) on conventional semen parameters remains controversial. Only a few systematic reviews and meta-analyses (SRMAs) have evaluated the impact of VR on sperm concentration, total motility, and progressive motility, mostly using a before-after analytic approach. No SRMA to date has evaluated the change in conventional semen parameters after VR compared to untreated controls. This study aimed to evaluate the effect of VR on conventional semen parameters in infertile patients with clinical varicocele compared to untreated controls. A literature search was performed using Scopus, PubMed, Embase, and Cochrane databases following the Population Intervention Comparison Outcome (PICOS) model (Population: infertile patients with clinical varicocele; Intervention: VR [any technique]; Comparison: infertile patients with clinical varicocele that were untreated; Outcome: sperm concentration, sperm total count, progressive sperm motility, total sperm motility, sperm morphology, and semen volume; Study type: randomized controlled trials and observational studies). A total of 1,632 abstracts were initially assessed for eligibility. Sixteen studies were finally included with a total of 2,420 infertile men with clinical varicocele (1,424 patients treated with VR vs. 996 untreated controls). The analysis showed significantly improved post-operative semen parameters in patients compared to controls with regards to sperm concentration (standardized mean difference [SMD] 1.739; 95% CI 1.129 to 2.349; p<0.001; I²=97.6%), total sperm count (SMD 1.894; 95% CI 0.566 to 3.222; p<0.05; I²=97.8%), progressive sperm motility (SMD 3.301; 95% CI 2.164 to 4.437; p<0.01; I²=98.5%), total sperm motility (SMD 0.887; 95% CI 0.036 to 1.738; p=0.04; I²=97.3%) and normal sperm morphology (SMD 1.673; 95% CI 0.876 to 2.470; p<0.05; I²=98.5%). All the outcomes showed a high inter-study heterogeneity, but the sensitivity analysis showed that no study was sensitive enough to change these results. Publication bias was present only in the analysis of the sperm concentration and progressive motility. No significant difference was found for the semen volume (SMD 0.313; 95% CI -0.242 to 0.868; I²=89.7%). This study provides a high level of evidence in favor of a positive effect of VR to improve conventional semen parameters in infertile men with clinical varicocele. To the best of our knowledge, this is the first SRMA to compare changes in conventional semen parameters after VR with changes in parameters of a control group over the same period. This is in contrast to other SRMAs which have compared semen parameters before and after VR, without reference to a control group. Our findings strengthen the available evidence and have a potential to upgrade professional societies' practice recommendations favoring VR to improve conventional semen parameters in infertile men.