The Prevalence, Etiological Agents, Clinical Features, Treatment, and Diagnosis of HIV-Associated Oral Candidiasis in Pediatrics Across the World: A Systematic Review and Meta-Analysis

In HIV-infected pediatrics, oral candidiasis (OC) is a global issue of concern due to its association with dysphagia, malnutrition, and mortality. The present systematic review and meta-analysis are the first to determine the prevalence of OC in HIV-infected pediatrics worldwide. We searched international (PubMed, Web of Science, Scopus, and Embase) databases for studies published between January 2000 to May 2020 reporting the epidemiologic features of OC in HIV-infected pediatrics. Inclusion and exclusion criteria were defined to select eligible studies. Data were extracted and presented according to PRISMA guidelines. The results of the meta-analysis were visualized as a forest plot. Heterogeneity was also analyzed using the I2, and τ2 statistics. The publication bias was evaluated using Egger test. The literature search revealed 1926 studies, of which 34 studies met the eligibility criteria, consisting of 4,474 HIV-infected pediatrics from 12 different countries. The overall prevalence of OC among HIV-infected pediatrics was 23.9% (95% CI 17.3–32.0%), and Candida albicans was the most prevalent etiologic agent. Pseudomembranous candidiasis was the predominant clinical manifestation in HIV-infected pediatrics suffering from OC. Thirty articles involving 4,051 individuals provided data on HIV treatment status. Among the 4,051 individuals, 468 (11.53%) did not receive HIV treatment. The data from 11 articles demonstrated that HIV treatment was significantly associated with a reduction in oral Candida colonization or infection. In contrast, others showed the opposite relationship or did not report any statistical data. A high level of I2 (I2 = 96%, P < 0.01) and τ2 (τ2 = 1.36, P < 0.01) was obtained among studies, which provides evidence of notable heterogeneity between studies. OC is approximately frequent in HIV-positive children. Therefore, efforts should be made to teach dental and non-dental clinicians who care for HIV-infected pediatrics to diagnose and treat this infection.

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Lactobacillus Reuteri DSM 17938 in Infantile Colic: A Systematic Review and Meta-Analysis

BioScientia Medicina ◽

10.37275/bsm.v6i3.457 ◽

2022 ◽

Vol 6 (3) ◽

pp. 1446-1454

Author(s):

Burhannudin Ichsan ◽

Nining Lestari ◽

Sulistyani

Keyword(s):

Systematic Review ◽

Lactobacillus Reuteri ◽

Controlled Trial ◽

Meta Analysis ◽

Forest Plot ◽

Infantile Colic ◽

Eligibility Criteria ◽

Randomized Controlled ◽

Infant Colic ◽

Systematic Synthesis

Background. Infantile colic, defined as paroxysmal, excessive, and consolable crying without an identifiable cause. It is common in the first 3 months of life. There have been many RCT studies conducted. A systematic synthesis is required to summarize the results of these RCTs. This study was aimed to systematically analyze the benefits of Lactobacillus reuteri DSM 17938 for infantile colic. Methods. This systematic review and meta-analysis used keywords: (“infantile colic” OR “abdominal cramps” OR “abdominal cramp” OR “infant colic”) AND “lactobacillus reuteri” AND (placebo OR placebos) AND (“randomized controlled trial” OR RCT). The databases used were: pubmed, science direct, and google scholar. Meta-analysis was conducted to combine the articles. The eligibility criteria were: patient with infantile colic, intervention with L. reuteri DSM 17938, control was placebo, RCT study design, outcome with dichotomous scale, all races, all ethnicities, all countries, all genders, in English, and not limited by year. Results. The search resulted in 800 articles. After reducing duplication, the number of articles was 747. Screening with titles and abstracts resulted in 13 full teks articles. Six articles fitted the eligibility criteria. The results of the meta-analysis were as follows. The forest plot showed that the combined effect of the six articles showed an RR of 0.47 and was statistically significant (p <0.001). Conclusion. Based on the results of this meta-analysis, L. reuteri DSM 17938 is recommended for infants with infantile colic. There were no significant side effects with the use of L. reuteri DSM 17938 on infantile colic.

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Magnitude of asymptomatic COVID-19 cases throughout the course of infection: A systematic review and meta-analysis

PLoS ONE ◽

10.1371/journal.pone.0249090 ◽

2021 ◽

Vol 16 (3) ◽

pp. e0249090

Author(s):

Muluneh Alene ◽

Leltework Yismaw ◽

Moges Agazhe Assemie ◽

Daniel Bekele Ketema ◽

Belayneh Mengist ◽

...

Keyword(s):

Public Health ◽

Systematic Review ◽

Meta Analysis ◽

Public Health Practice ◽

Scale Up ◽

Public Health Intervention ◽

Forest Plot ◽

Eligibility Criteria ◽

High Risk Populations ◽

Leave One Out

Background Asymptomatic SARS-CoV-2 infections are responsible for potentially significant transmission of COVID-19. Worldwide, a number of studies were conducted to estimate the magnitude of asymptomatic COVID-19 cases. However, there is a need for more robust and well-designed studies to have a relevant public health intervention. Synthesis of the available studies significantly strengthens the quality of evidences for public health practice. Thus, this systematic review and meta-analysis aimed to determine the overall magnitude of asymptomatic COVID-19 cases throughout the course of infection using available evidences. Methods We followed the PRISMA checklist to present this study. Two experienced review authors (MA and DBK) were systematically searched international electronic databases for studies. We performed meta-analysis using R statistical software. The overall weighted proportion of asymptomatic COVID-19 cases throughout the course infection was computed. The pooled estimates with 95% confidence intervals were presented using forest plot. Egger’s tests were used to assess publication bias, and primary estimates were pooled using a random effects model. Furthermore, a sensitivity analysis was conducted to assure the robustness of the result. Results A total of 28 studies that satisfied the eligibility criteria were included in this systematic review and meta-analysis. Consequently, in the meta-analysis, a total of 6,071 COVID-19 cases were included. The proportion of asymptomatic infections among the included studies ranged from 1.4% to 78.3%. The findings of this meta-analysis showed that the weighted pooled proportion of asymptomatic COVID-19 cases throughout the course of infection was 25% (95%CI: 16–38). The leave-one out result also revealed that the weighted pooled average of asymptomatic SARS-CoV-2 infection was between 28% and 31.4%. Conclusions In conclusion, one-fourth of SARS-CoV-2 infections are remained asymptomatic throughout the course infection. Scale-up of testing, which targeting high risk populations is recommended to tackle the pandemic.

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Immunomodulatory and Mechanistic Considerations of Hibiscus sabdariffa (HS) in Dysfunctional Immune Responses: A Systematic Review

Frontiers in Immunology ◽

10.3389/fimmu.2021.550670 ◽

2021 ◽

Vol 12 ◽

Author(s):

Francis U. Umeoguaju ◽

Benson C. Ephraim-Emmanuel ◽

Joy O. Uba ◽

Grace E. Bekibele ◽

Nwondah Chigozie ◽

...

Keyword(s):

Systematic Review ◽

Animal Studies ◽

Meta Analysis ◽

Forest Plot ◽

Hibiscus Sabdariffa ◽

Eligibility Criteria ◽

Edema Formation ◽

Monocyte Chemoattractant Protein 1 ◽

Immune Biomarkers ◽

Statistical Heterogeneity

Hibiscus sabdariffa calyx (HS) water decoction extract is a commonly consumed beverage with various pharmacological properties. This systematic review examines the possible effect of HS intake on immune mediators. The Scopus and PUBMED databases were searched for all human and animal studies that investigated the effect of HS administration on immune related biomarkers. For each of the immune biomarkers, the mean, standard deviation and number of subjects were extracted for both the HS treated and untreated group. These values were used in the computation of standardized mean difference (SMD). Statistical analysis and forest plot were done with R statistical software (version 3.6.1). Twenty seven (27) studies met the eligibility criteria. Twenty two (22) of the studies were used for the meta-analysis which included a total of 1211 subjects. The meta-analysis showed that HS administration significantly lowered the levels of TNF-α (n=10; pooled SMD: -1.55; 95% CI: -2.43, -0.67; P < 0.01), IL-6 (n=11; pooled SMD:-1.09; 95% CI: -1.77, -0.40; P < 0.01), IL-1β (n=7; pooled SMD:-0.62; 95% CI: -1.25, 0.00; P = 0.05), Edema formation (n=4; pooled SMD: -2.29; 95% CI: -4.47, -0.11; P = 0.04), Monocyte Chemoattractant Protein -1 (n=4; pooled SMD: -1.17; 95% CI: -1.78, -0.57; P < 0.01) and Angiotensin converting enzyme cascade (n=6; pooled SMD: -0.91; 95% CI: -1.57, -0.25; P < 0.01). The levels of IL-10 (n=4; pooled SMD: -0.38; 95% CI: -1.67, 0.91; P = 0.56), Interleukin 8 (n=2; pooled SMD:-0.12; 95% CI: -0.76, 0.51; P = 0.71), iNOS (n=2; pooled SMD:-0.69; 95% CI: -1.60, 0.23 P = 0.14) and C- Reactive Protein (n=4; pooled SMD: 0.05; 95% CI: -0.26, 0.36; P = 0.75), were not significantly changed by HS administration. Some of the results had high statistical heterogeneity. HS may be promising in the management of disorders involving hyperactive immune system or chronic inflammation.

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Use of antioxidants supplementation on developmental outcomes in children with Down Syndrome - a systematic review and meta-analyses

10.21203/rs.3.rs-159586/v1 ◽

2021 ◽

Author(s):

Sidra Kaleem Jafri ◽

Atiya Iqbal ◽

Anusha Alam ◽

Julia Frei ◽

Zohra Lassi

Keyword(s):

Systematic Review ◽

Down Syndrome ◽

Pediatric Population ◽

Meta Analysis ◽

Developmental Outcomes ◽

Forest Plot ◽

Random Allocation ◽

Eligibility Criteria ◽

Randomized Controlled ◽

Randomized Controlled Studies

Abstract AIM To evaluate the published literature on the use of antioxidants in improving developmental outcomes in DS children METHODS The systematic review included interventional studies (randomized controlled trials (RCTs) and quasi-RCTs (q-RCTs)) on children between the ages of 0 to 18 years diagnosed with DS and used antioxidants for improving developmental outcomes, and compered with similar children given placebo or no supplementation. Aim was to have a true randomized population for intervention, thus RCTs and quasi- RCTs were included. Studies were excluded if those were non-randomized controlled studies (including observational studies, systematic and narrative review articles, editorials and commentaries) with no random allocation and no comparison group. We also excluded studies if data from participants with DS was included as part of a larger group of participants (e.g. children with intellectual disability) and could not be separated for subgroup analysis, and studies that did not assess developmental domains and only assessed biochemical markers. The review included children with other conditions associated with developmental disability, only when data for children with DS were separately reported. RESULTS Eleven RCTs and q-RCTs fulfilled the eligibility criteria with 683 participants with Down syndrome, with age range of newborns to 17 years of age. Eight studies did not show any statistically significant clinical benefit of using antioxidants. A meta-analysis was applied to compare changes in the effect sizes (post and pre-intervention) in GDQ between the intervention and control groups. The forest plot including the three studies doesn’t demonstrate a statistically significant improvement. INTERPRETATION This review concludes that the use of antioxidants does not improve the developmental outcomes in pediatric population with DS.

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Chasing the Anchor: A Systematic Review and Meta-analysis of Perceptual Anchoring Deficits in Developmental Dyslexia

10.31234/osf.io/amzpj ◽

2020 ◽

Author(s):

Kurt D Shulver ◽

Nicholas A Badcock

Keyword(s):

Systematic Review ◽

Reading Ability ◽

English Language ◽

Prediction Interval ◽

Meta Analysis ◽

Visual Assessment ◽

Individual Performance ◽

Future Research ◽

Significant Heterogeneity ◽

Eligibility Criteria

We report the results of a systematic review and meta-analysis investigating the relationship between perceptual anchoring and dyslexia. Our goal was to assess the direction and degree of effect between perceptual anchoring and reading ability in typical and atypical (dyslexic) readers. We performed a literature search of experiments explicitly assessing perceptual anchoring and reading ability using PsycInfo (Ovid, 1860 to 2020), MEDLINE (Ovid, 1860 to 2019), EMBASE (Ovid, 1883 to 2019), and PubMed for all available years up to June (2020). Our eligibility criteria consisted of English-language articles and, at minimum, one experimental group identified as dyslexic - either by reading assessment at the time, or by previous diagnosis. We assessed for risk of bias using an adapted version of the Newcastle-Ottawa scale. Six studies were included in this review, but only five (n = 280 participants) were included in the meta-analysis (we were unable to access the necessary data for one study).The overall effect was negative, large and statistically significant; g = -0.87, 95% CI [-1.47, 0.27]: a negative effect size indicating less perceptual anchoring in dyslexic versus non-dyslexic groups. Visual assessment of funnel plot and Egger’s test suggest minimal bias but with significant heterogeneity; Q (4) = 9.70, PI (prediction interval) [-2.32, -0.58]. The primary limitation of the current review is the small number of included studies. We discuss methodological limitations, such as limited power, and how future research may redress these concerns. The variability of effect sizes appears consistent with the inherent variability within subtypes of dyslexia. This level of dispersion seems indicative of the how we define cut-off thresholds between typical reading and dyslexia populations, but also the methodological tools we use to investigate individual performance.

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Running and Knee Osteoarthritis: A Systematic Review and Meta-analysis

The American Journal of Sports Medicine ◽

10.1177/0363546516657531 ◽

2016 ◽

Vol 45 (6) ◽

pp. 1447-1457 ◽

Cited By ~ 38

Author(s):

Kate A. Timmins ◽

Richard D. Leech ◽

Mark E. Batt ◽

Kimberley L. Edwards

Keyword(s):

Systematic Review ◽

Full Text ◽

Meta Analysis ◽

Positive Association ◽

Case Control ◽

Case Control Studies ◽

Eligibility Criteria ◽

Knee Oa ◽

Knee Joint Surgery ◽

Newcastle Ottawa Scale

Background: Osteoarthritis (OA) is a chronic condition characterized by pain, impaired function, and reduced quality of life. A number of risk factors for knee OA have been identified, such as obesity, occupation, and injury. The association between knee OA and physical activity or particular sports such as running is less clear. Previous reviews, and the evidence that informs them, present contradictory or inconclusive findings. Purpose: This systematic review aimed to determine the association between running and the development of knee OA. Study Design: Systematic review and meta-analysis. Methods: Four electronic databases were searched, along with citations in eligible articles and reviews and the contents of recent journal issues. Two reviewers independently screened the titles and abstracts using prespecified eligibility criteria. Full-text articles were also independently assessed for eligibility. Eligible studies were those in which running or running-related sports (eg, triathlon or orienteering) were assessed as a risk factor for the onset or progression of knee OA in adults. Relevant outcomes included (1) diagnosis of knee OA, (2) radiographic markers of knee OA, (3) knee joint surgery for OA, (4) knee pain, and (5) knee-associated disability. Risk of bias was judged by use of the Newcastle-Ottawa scale. A random-effects meta-analysis was performed with case-control studies investigating arthroplasty. Results: After de-duplication, the search returned 1322 records. Of these, 153 full-text articles were assessed; 25 were eligible, describing 15 studies: 11 cohort (6 retrospective) and 4 case-control studies. Findings of studies with a diagnostic OA outcome were mixed. Some radiographic differences were observed in runners, but only at baseline within some subgroups. Meta-analysis suggested a protective effect of running against surgery due to OA: pooled odds ratio 0.46 (95% CI, 0.30-0.71). The I2 was 0% (95% CI, 0%-73%). Evidence relating to symptomatic outcomes was sparse and inconclusive. Conclusion: With this evidence, it is not possible to determine the role of running in knee OA. Moderate- to low-quality evidence suggests no association with OA diagnosis, a positive association with OA diagnosis, and a negative association with knee OA surgery. Conflicting results may reflect methodological heterogeneity. More evidence from well-designed, prospective studies is needed to clarify the contradictions.

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Psychological and Behavioral Impact of Lockdown and Quarantine Measures for COVID-19 Pandemic on Children, Adolescents and Caregivers: A Systematic Review and Meta-Analysis

Journal of Tropical Pediatrics ◽

10.1093/tropej/fmaa122 ◽

2020 ◽

Author(s):

Prateek Kumar Panda ◽

Juhi Gupta ◽

Sayoni Roy Chowdhury ◽

Rishi Kumar ◽

Ankit Kumar Meena ◽

...

Keyword(s):

Systematic Review ◽

Sleep Disturbance ◽

Behavioral Problems ◽

Meta Analysis ◽

Random Effect ◽

Psychological Problems ◽

Psychological State ◽

Eligibility Criteria ◽

Behavioral Abnormalities ◽

Anxiety Depression

Abstract Background During the current ongoing COVID-19 pandemic, psychological problems like anxiety, depression, irritability, mood swings, inattention and sleep disturbance are fairly common among quarantined children in several studies. A systematic review of these publications to provide an accurate burden of these psychiatric/behavioral problems is needed for planning mitigating measures by the health authorities. Methods Different electronic databases (MEDLINE, EMBASE, Web of Science, CENTRAL, medRxiv and bioRxiv) were searched for articles describing psychological/behavioral complications in children/adolescents with/without pre-existing behavioral abnormalities and their caregivers related to the COVID-19 pandemic. Only original articles with/without comparator arms and a minimum sample size of 50 were included in the analysis. The pooled estimate of various psychological/behavioral problems was calculated using a random-effect meta-analysis. Results Fifteen studies describing 22 996 children/adolescents fulfilled the eligibility criteria from a total of 219 records. Overall, 34.5%, 41.7%, 42.3% and 30.8% of children were found to be suffering from anxiety, depression, irritability and inattention. Although the behavior/psychological state of a total of 79.4% of children was affected negatively by the pandemic and quarantine, at least 22.5% of children had a significant fear of COVID-19, and 35.2% and 21.3% of children had boredom and sleep disturbance. Similarly, 52.3% and 27.4% of caregivers developed anxiety and depression, respectively, while being in isolation with children. Conclusion Anxiety, depression, irritability, boredom, inattention and fear of COVID-19 are predominant new-onset psychological problems in children during the COVID-19 pandemic. Children with pre-existing behavioral problems like autism and attention deficit hyperactivity disorder have a high probability of worsening of their behavioral symptoms.

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671 Update of a systematic review and meta-analysis studying the association between antibiotic use and clinical outcomes of non-small-cell lung cancer patients treated with immune checkpoint inhibitors

Journal for ImmunoTherapy of Cancer ◽

10.1136/jitc-2020-sitc2020.0671 ◽

2020 ◽

Vol 8 (Suppl 3) ◽

pp. A708-A708

Author(s):

Pierre-Alain Bandinelli ◽

Julie Cervesi ◽

Clément Le Bescop ◽

Renaud Buffet ◽

Jean De Gunzburg ◽

...

Keyword(s):

Systematic Review ◽

Clinical Outcomes ◽

Time Window ◽

Checkpoint Inhibitors ◽

Meta Analysis ◽

Progression Free Survival ◽

Antibiotic Use ◽

Forest Plot ◽

Antibiotic Exposure ◽

Hazard Ratios

BackgroundImmune checkpoint inhibitors (ICIs) have been shown to improve patients‘ clinical outcomes in a variety of cancers, but with variable efficacy. Prior research has also suggested that systemic antibiotic (ABX) exposure may impact the intestinal microbiota and result in suboptimal ICI treatment outcomes. Our team published a systematic review and meta-analysis showing that ABX use could indeed decrease the survival of patients diagnosed with non-small-cell lung cancer (NSCLC) and treated with ICIs.1 The present abstract aims at updating this meta-analysis by incorporating new studies that have been published in the period ranging from September 2019 to August 2020.MethodsMedline (through PubMed), the Cochrane Library and major oncology conferences proceedings were systematically searched to identify studies assessing the impact of ABX use on the clinical outcomes of NSCLC patients treated with ICIs. Studies were found eligible for inclusion when they mentioned a hazard ratio (HR) or Kaplan–Meier curves for overall survival (OS) or progression-free survival (PFS) based on antibiotic exposure. Pooled HRs for OS and PFS and HRs for OS and PFS according to different time windows for ABX exposure were calculated.Results6 eligible new studies were identified between September 2019 and August 2020 while 3 other studies were updated with new information. Altogether, 27 studies reported data for OS (6,436 patients, 826 of whom coming from new studies) and 24 for PFS (3,751 patients, 786 of whom coming from new studies). The pooled HR was 1.75 (95% confidence interval [CI]: 1.38–2.23) for OS and 1.57 (95% CI: 1.28–1.92) for PFS, confirming a significantly reduced survival in patients with NSCLC exposed to ABX. The detailed analysis in subgroups based on the time window of exposure (figure 1, figure 2) suggests that the deleterious effect of ABX is stronger when the exposition happens shortly before and after the initiation of the ICI treatment.Abstract 671 Figure 1Forest plot of hazard ratios for overall survival of patients diagnosed with NSCLC and exposed to antibiotics versus not exposed to antibiotics, according to the time window of antibiotic exposureAbstract 671 Figure 2Forest plot of hazard ratios for progression-free survival of patients diagnosed with NSCLC and exposed to antibiotics versus not exposed to antibiotics, according to the time window of antibiotic exposureConclusionsThe update of the meta-analysis confirms the previously reported deleterious effect of ABX on ICI treatment outcomes, taking into account the latest publications in the field. The topic deserves further research to uncover if the effect will stand with 1st line use of ICI together with chemotherapies and/or other approved combinations, elucidate the mechanisms at stake and improve care of patients.ReferencesLurienne L, Cervesi J, Duhalde L, de Gunzburg J, Andremont A, Zalcman G, et al. NSCLC immunotherapy efficacy and antibiotic use: a systematic review and meta-analysis. J Thorac Oncol 2020;15:1147–1159.

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The use of eHealth to promote physical activity in people living with Parkinson’s disease: A systematic review

Physiotherapy Practice and Research ◽

10.3233/ppr-200474 ◽

2021 ◽

pp. 1-14

Author(s):

Adam McDermott ◽

Ciaran Haberlin ◽

Jonathan Moran

Keyword(s):

Physical Activity ◽

Systematic Review ◽

Parkinson’S Disease ◽

Parkinson's Disease ◽

Risk Of Bias ◽

Attrition Rate ◽

Medical Subject Headings ◽

Eligibility Criteria ◽

Ehealth Intervention ◽

High Level

BACKGROUND: People living with Parkinson’s disease (PD) are less active than healthy individuals. Ehealth is an emerging concept in healthcare which presents opportunities to promote physical activity (PA) in people with PD. The aim of this systematic review was to explore the effectiveness of ehealth in the promotion of PA in people living with PD. METHODS: Suitable articles were searched for using EMBASE, PsychInfo, Web of Science and OVID Medline databases using a combination of keywords and medical subject headings. Articles were included if they described an ehealth intervention designed to promote PA in people living with PD. Two reviewers screened studies for suitability and extracted data. Risk of bias was assessed using the Cochrane risk of bias 2 tool and the Downs and Black risk of bias checklist. Due to the heterogeneity of studies, a narrative synthesis of study interventions and results was completed rather than a quantitative analysis. RESULTS: 1449 articles were screened. Four studies met the eligibility criteria which included 652 participants. Web and mobile applications were used to design the PA interventions. PA levels were measured using self-reported questionnaires, Fitbits, activity monitors and accelerometers. Three of the studies reported improvements in aspects of PA. However, this was not consistently reported in all study participants. No adverse effects, a high level of enjoyment and a relatively low attrition rate (∼12.5%) were reported. CONCLUSION: Ehealth is a safe and feasible intervention to promote PA in this population. It is unclear whether ehealth is effective at promoting PA in people with PD. Keywords:

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Tolerability of statin-based management of patients with a history of statin-associated muscle symptoms: protocol for a systematic review

BMJ Open ◽

10.1136/bmjopen-2021-052341 ◽

2021 ◽

Vol 11 (8) ◽

pp. e052341

Author(s):

Fanny Villoz ◽

Christina Lyko ◽

Cinzia Del Giovane ◽

Nicolas Rodondi ◽

Manuel R Blum

Keyword(s):

Systematic Review ◽

Meta Analysis ◽

Mean Difference ◽

Control Group ◽

Cochrane Central Register ◽

Eligibility Criteria ◽

Clinical Issue ◽

Standard Data ◽

Evaluation Approach ◽

History Of

IntroductionStatin-associated muscle symptoms (SAMSs) are a major clinical issue in the primary and secondary prevention of cardiovascular events. Current guidelines advise various approaches mainly based on expert opinion. We will lead a systematic review and meta-analysis to explore the tolerability and acceptability and effectiveness of statin-based therapy management of patients with a history of SAMS. We aim to provide evidence on the tolerability and different strategies of statin-based management of patients with a history of SAMS.Methods and analysisWe will conduct a systematic review of randomised controlled trials (RCTs) and non-randomised studies with a control group. We will search in Data sources MEDLINE, EMBASE, Cochrane Central Register of Controlled Clinical Trials, Scopus, Clinicaltrials.gov and Proquest from inception until April 2021. Two independent reviewers will carry out the study selection based on eligibility criteria. We will extract data following a standard data collection form. The reviewers will use the Cochrane Collaboration’s tools and Newcastle-Ottawa Scale to appraise the study risk of bias. Our primary outcome will be tolerability and our secondary outcomes will be acceptability and effectiveness. We will conduct a qualitative analysis of all included studies. In addition, if sufficient and homogeneous data are available, we will conduct quantitative analysis. We will synthesise dichotomous data using OR with 95% CI and continuous outcomes by using mean difference or standardised mean difference (with 95% CI). We will determine heterogeneity visually with forest plots and quantitatively with I2 and Q-test. We will summarise the confidence in the quantitative estimate by using Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationAs a systematic review of literature without collection of new clinical data, there will be no requirement for ethical approval. We will disseminate findings through peer-reviewed publications.PROSPERO registration numberCRD42020202619.

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