scholarly journals Publication Rate and Consistency of Registered Trials of Motor-Based Stroke Rehabilitation

Neurology ◽  
2021 ◽  
Vol 96 (13) ◽  
pp. 617-626
Author(s):  
Raabeae Aryan ◽  
David Jagroop ◽  
Cynthia J. Danells ◽  
Gabriela Rozanski ◽  
Janelle Unger ◽  
...  

ObjectiveTo determine the publication rate of motor-rehabilitation trials poststroke and the consistency between registry records and their corresponding main publications in trial design, primary objectives and outcomes, eligibility criteria, and sample size.MethodsWe searched 18 clinical trial registries to identify randomized controlled trials of motor-based stroke rehabilitation registered after July 2005 and completed before April 2017. Eligible trials included adults with stroke, with at least one outcome measure related to motor function. Information in the registry records was compared with that of their main publications, if any.ResultsThree hundred twenty-three trials met our eligibility criteria; we were unable to find a peer-reviewed publication reporting the main findings for 46% (150/323) of these. Of the 169 trials with peer-reviewed articles published in English, 141 (83%) were consistent with the registry record in trial design, 100 (59%) were consistent in primary objectives, 71 (42%) were consistent in primary outcomes, 28 (17%) were consistent in eligibility criteria, and 74 (44%) were consistent in sample size.ConclusionsApproximately half of motor-based stroke rehabilitation trials were not published, even more than 3 years after the end of the trial. When main publications were found, they substantially deviated from information in the registry record. These findings highlight the importance of trial registries for identifying unpublished stroke rehabilitation trials and of searching trial registries when conducting systematic reviews and meta-analysis to help ensure that reviews are unbiased.

2020 ◽  
pp. bjsports-2020-102823
Author(s):  
Larissa Santos Pinto Pinheiro ◽  
Juliana Melo Ocarino ◽  
Fernanda Oliveira Madaleno ◽  
Evert Verhagen ◽  
Marco Túlio de Mello ◽  
...  

ObjectiveTo investigate prevalence, incidence and profile of musculoskeletal injuries in para athletes.DesignSystematic review.Data sourcesSearches were conducted in MEDLINE, EMBASE, AMED, SPORTSDiscus, CINAHL and hand searching.Eligibility criteriaStudies were considered if they reported prevalence or incidence of musculoskeletal injuries in para athletes. Study selection, data extraction and analysis followed the protocol. Meta-analyses were conducted to estimate the prevalence and incidence rate among studies and subgroup analyses investigated whether methodological quality and sample size of the studies influenced on the estimated injury prevalence and incidence. The Grading of Recommendations Assessment, Development and Evaluation system determined the strength of evidence.ResultsForty-two studies were included. The prevalence of musculoskeletal injuries was 40.8% (95% CI 32.5% to 49.8%). Because of imprecision, indirectness and inconsistency, the strength of evidence was very low quality. The incidence of musculoskeletal injuries was 14.3 injuries per 1000 athlete-days (95% CI 11.9 to 16.8). The strength of evidence was low quality because of imprecision and indirectness. The subgroup analyses revealed that the sample size influenced on estimated injury prevalence and methodological quality influenced on estimated incidence. Injuries were more prevalent in the shoulder, for non-ambulant para athletes, and in the lower limbs, for ambulant para athletes.Summary/conclusionPara athletes show high prevalence and incidence of musculoskeletal injuries. Current very low-quality and low-quality evidence suggests that future high-quality studies with systematic data collection, larger sample size and specificities of para athletes are likely to change estimates of injury prevalence and incidence in para athletes.PROSPERO registration numberCRD42020147982.


2021 ◽  
Author(s):  
Simon Arsène ◽  
Claire Couty ◽  
Igor Faddeenkov ◽  
Natacha Go ◽  
Solène Granjeon-Noriot ◽  
...  

Clinical research in infectious respiratory diseases has been profoundly affected by non-pharmaceutical interventions (NPIs) against COVID-19. On top of trial delays or even discontinuation which have been observed in all disease areas, NPIs altered transmission pattern of many seasonal respiratory viruses which followed regular patterns for decades before the pandemic. Clinical trial design based on pre-pandemic historical data therefore needs to be put in question. In this article, we show how knowledge-based mathematical modeling can be used to address this issue. We set up an epidemiological model of respiratory tract infection (RTI) sensitive to a time dependent between-host transmission rate and coupled this model to a mechanistic description of viral RTI episodes in an individual patient. By reducing the transmission rate when the lockdown was introduced in the United Kingdom in March 2020, we were able to reproduce the perturbed 2020 RTI disease burden data. Using this setup, we simulated several NPIs scenarios of various strength (none, mild, medium, strong) and conducted placebo-controlled in silico clinical trials in pediatric patients with recurrent RTIs (RRTI) quantifying annual RTI rate distributions. In interventional arms, virtual patients aged 1-5 years received the bacterial lysate OM-85 (approved in several countries for the prevention of pediatric RRTIs) through a pro-type I immunomodulation mechanism of action described by a physiologically based pharmacokinetics and pharmacodynamics approach (PBPK/PD). Our predictions showed that sample size estimates based on the ratio of RTI rates (or the post-hoc power of fixed sample size trials) are not majorly impacted under NPIs which are less severe (none, mild and medium NPIs) than a strict lockdown (strong NPI). However, NPIs show a stronger impact on metrics more relevant for assessing the clinical relevance of the effect such as absolute benefit. This dichotomy shows the risk that successful trials (even with their primary endpoints being met) still get challenged in risk benefit assessment during the review of market authorization. Furthermore, we found that a mild NPI scenario already affected the time to recruit significantly when sticking to eligibility criteria complying with historical data. In summary, our model predictions can help rationalize and forecast post-COVID-19 trial feasibility. They advocate for gauging absolute and relative benefit metrics as well as clinical relevance for assessing efficacy hypotheses in trial design and they question eligibility criteria misaligned with the actual disease burden.


2020 ◽  
Author(s):  
Morteza Arab-Zozani ◽  
Soheil Hassanipour ◽  
Djavad Ghoddoosi-Nejad

Abstract Background An outbreak of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) was reported in Wuhan, China in mid-December 2019, and declared a pandemic by the World Health Organization (WHO) on March 11, 2020. Due to the unknown nature of the disease and the lack of specific drugs, several potential treatments were used for patients. This systematic review and meta-analysis will evaluate studies of the effects of Favipiravir in COVID-19 pneumonia. Methods We will search electronic databases including LitCovid hub, PubMed, Scopus, ISI web of Sciences, Cochrane, and Embase using keywords related to COVID-19 and Favipiravir. We will search the reference lists of all included studies and reviews. We will also search for clinical trial registries, such as clinicaltrial.gov for the ongoing clinical trials. Two investigators (MAZ and SH) will independently screen titles, abstracts, and full-text of included studies based on eligibility criteria. These investigators will also independently extract data and appraise the quality of studies. All potential discrepancies will be resolved through consultation with the third reviewer. Data synthesis will be conducted using the Review Manager software (version 5.3) or CMA (version 2). Statistical heterogeneity will be assessed using a standard I 2 test. A funnel plot, Egger’s test, and Begg’s test will be used for asymmetry to explore possible publication bias. Discussion The findings of this systematic review with proportional meta-analysis will help to identify the safety and efficacy of Favipiravir for COVID-19 patients. Knowledge gained from this research will also assist physicians in selecting better treatment options and developing a guideline in this field.


Author(s):  
Morteza Arab-zozani ◽  
Soheil Hassanipour ◽  
Djavad Ghoddoosi-Nejad

AbstractIntroductionAn outbreak of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) was reported in Wuhan, China in mid-December 2019, and declared a pandemic by the World Health Organization (WHO) on March 11, 2020. Due to the unknown nature of the disease and the lack of specific drugs, several potential treatments were used for patients. This systematic review and meta-analysis will evaluate studies of the effects of Favipiravir in COVID-19 pneumonia.Methods and analysisWe will search electronic databases including LitCovid hub, PubMed, Scopus, ISI web of Sciences, Cochrane, and Embase using keywords related to COVID-19 and Favipiravir. We will search the reference lists of all included studies and reviews. We will also search for clinical trial registries, such as clinicaltrial.gov for the ongoing clinical trials. Two investigators (MAZ and SH) will independently screen titles, abstracts, and full-text of included studies based on eligibility criteria. These investigators will also independently extract data and appraise the quality of studies. All potential discrepancies will be resolved through consultation with the third reviewer. Data synthesis will be conducted using the Review Manager software (version 5.3) or CMA (version 2). Statistical heterogeneity will be assessed using a standard I2 test. A funnel plot, Egger’s test, and Begg’s test will be used for asymmetry to explore possible publication bias.Ethics and disseminationThe findings of this systematic review with proportional meta-analysis will help to identify the safety and efficacy of Favipiravir for COVID-19 patients. Knowledge gained from this research will also assist physicians in selecting better treatment options and developing a guideline in this field.Strengths and limitations of this studyIn the protocol, all stage of study conducted by two reviewers independently and supervised by a third reviewer.This systematic review may produce the first meta-analysis that provides evidence regarding the safety and effectiveness of favipiravir on COVID-19 patients.The small number of studies published in this field when writing a protocol can be one of the most important limitations.PROSPERO registration number: CRD42020180032


2020 ◽  
Vol 45 (6) ◽  
pp. 589-597
Author(s):  
BGS Casado ◽  
EP Pellizzer ◽  
JR Souto Maior ◽  
CAA Lemos ◽  
BCE Vasconcelos ◽  
...  

Clinical Relevance The use of laser light during bleaching will not reduce the incidence or severity of sensitivity and will not increase the degree of color change compared with nonlaser light sources. SUMMARY Objective: To evaluate whether the use of laser during in-office bleaching promotes a reduction in dental sensitivity after bleaching compared with other light sources. Methods: The present review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and is registered with PROSPERO (CDR42018096591). Searches were conducted in the PubMed/Medline, Web of Science, and Cochrane Library databases for relevant articles published up to August 2018. Only randomized clinical trials among adults that compared the use of laser during in-office whitening and other light sources were considered eligible. Results: After analysis of the texts retrieved during the database search, six articles met the eligibility criteria and were selected for the present review. For the outcome dental sensitivity, no significant difference was found favoring any type of light either for intensity (mean difference [MD]: −1.60; confidence interval [CI]: −3.42 to 0.22; p=0.09) or incidence (MD: 1.00; CI: 0.755 to 1.33; p=1.00). Regarding change in tooth color, no significant differences were found between the use of the laser and other light sources (MD: −2.22; CI: −6.36 to 1.93; p=0.29). Conclusions: Within the limitations of the present study, laser exerts no influence on tooth sensitivity compared with other light sources when used during in-office bleaching. The included studies demonstrated that laser use during in-office bleaching may have no influence on tooth color change.


2020 ◽  
Author(s):  
Kurt D Shulver ◽  
Nicholas A Badcock

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.


2020 ◽  
Vol 16 (3) ◽  
pp. 265-283
Author(s):  
Kyriaki Hatziagapiou ◽  
George I. Lambrou

Background: Reactive oxygen species and reactive nitrogen species, which are collectively called reactive oxygen nitrogen species, are inevitable by-products of cellular metabolic redox reactions, such as oxidative phosphorylation in the mitochondrial respiratory chain, phagocytosis, reactions of biotransformation of exogenous and endogenous substrata in endoplasmic reticulum, eicosanoid synthesis, and redox reactions in the presence of metal with variable valence. Among medicinal plants there is a growing interest in Crocus sativus L. It is a perennial, stemless herb, belonging to Iridaceae family, cultivated in various countries such as Greece, Italy, Spain, Israel, Morocco, Turkey, Iran, India, China, Egypt and Mexico. Objective: The present study aims to address the anti-toxicant role of Crocus sativus L. in the cases of toxin and drug toxification. Materials and Methods: An electronic literature search was conducted by the two authors from 1993 to August 2017. Original articles and systematic reviews (with or without meta-analysis), as well as case reports were selected. Titles and abstracts of papers were screened by a third reviewer to determine whether they met the eligibility criteria, and full texts of the selected articles were retrieved. Results: The authors focused on literature concerning the role of Crocus Sativus L. as an anti-toxicant agent. Literature review showed that Saffron is a potent anti-toxicant agent with a plethora of applications ranging from anti-oxidant properties, to chemotherapy protective effects. Conclusion: Literature findings represented in current review herald promising results for using Crocus Sativus L. and/or its active constituents as anti-toxicant, chemotherapy-induced protection and toxin protection.


2020 ◽  
Author(s):  
Arfan Ahmed ◽  
Nashva ALi ◽  
Sarah Aziz ◽  
Alaa A Abd-Alrazaq ◽  
Asmaa Hassan ◽  
...  

BACKGROUND Anxiety and depression rates are at an all-time high along with other mental health disorders. Smartphone-based mental health chatbots or conversational agents can aid psychiatrists and replace some of the costly human based interaction and represent a unique opportunity to expand the availability and quality of mental health services and treatment. Regular up-to-date reviews will allow medics and individuals to recommend or use anxiety and depression related smartphone based chatbots with greater confidence. OBJECTIVE Assess the quality and characteristics of chatbots for anxiety and depression available on Android and iOS systems. METHODS A search was performed in the App Store and Google Play Store following the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) protocol to identify existing chatbots for anxiety and depression. Eligibility of the chatbots was assessed by two individuals based on predefined eligibility criteria. Meta-data of the included chatbots and their characteristics were extracted from their description and upon installation by 2 reviewers. Finally, chatbots quality information was assessed by following the mHONcode principles. RESULTS Although around 1000 anxiety and depression related chatbots exist, only a few (n=11) contained actual chatbots that could provide the user a real substitute for a human-human based interaction, even with today's Artificial Intelligence advancements, only one of these chatbots had voice as an input/output modality. Of the selected apps that contained chatbots all were clearly built with a therapeutic human substitute goal in mind. The majority had high user ratings and downloads highlighting the popularity of such chatbots and their promising future within the realm of anxiety and depression. CONCLUSIONS Anxiety and depression chatbot apps have the potential to increase the capacity of mental health self-care providing much needed assistance to professionals. In the current covid-19 pandemic, chatbots can also serve as a conversational companion with the potential of combating loneliness, especially in lockdowns where there is a lack of social interaction. Due to the ubiquitous nature of chatbots users can access them on-demand at the touch of a screen on ones’ smartphone. Self-care interventions are known to be effective and exist in various forms and some can be made available as chatbot features, such as assessment, mood tracking, medicine tracking, or simply providing conversation in times of loneliness.


Author(s):  
Ya-Dong Wang ◽  
Yu-Xiang Ming ◽  
Yong-Hua Pang ◽  
Wei-Nan Chen ◽  
Xu-Hua Zong ◽  
...  

BACKGROUND: Persisting shoulder stiffness adversely affects quality of life by causing pain and motion restrictions especially in patients with diabetes. OBJECTIVE: The aim of this study was to evaluate the outcomes of arthroscopic capsular release in patients with idiopathic shoulder stiffness. METHOD: A literature search was conducted in electronic databases and studies were selected by following precise eligibility criteria. Random-effects meta-analyses were performed to estimate the changes at latest follow-up in scores of the Constant, American Shoulder and Elbow Surgeons (ASES), and University of California at Los Angelis (UCLA) scales, Visual Analogue Scale (VAS), and shoulder range of motion. RESULTS: Nineteen studies were included. The follow-up duration was 42 months [95% confidence interval (CI): 32, 51]. Improvements in scores of the Constant, ASES, UCLA scales, and VAS were 48.3 [95% CI: 38.0, 58.6], 44.6 [95% CI: 24.6, 64.6], 19.3 [95% CI: 16.6, 22.0], and -6.1 [95% CI: -6.9, -5.4] respectively (P< 0.05 all). Improvements in the shoulder range of motion were: abduction 82.0 [95% CI: 65.0, 98.9]; forward flexion 75.9 [95% CI: 59.7, 92.1]; external rotation 43.2 [95% CI: 37.5, 49.0]; and internal rotation 25.4 [95% CI: 15.2, 35.5] degrees; P< 0.05 all). CONCLUSION: Arthroscopic capsular release effectively improves shoulder function in patients with idiopathic shoulder stiffness.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Bin Liu ◽  
Xiang Meng ◽  
Yanfang Ma ◽  
Huizhen Li ◽  
Yuqi Liu ◽  
...  

Abstract Background Total glucosides of paeony (TGP), an active compound extracted from the roots of Paeonia lactiflora Pallas, has been increasingly used as the adjunctive therapy for rheumatoid arthritis (RA) patients. Though TGP could mitigate the unanticipated adverse effects during the conventional treatment of RA, high-quality evidence-based meta-analysis data on this subject are still insufficient. The objective of this study is to evaluate the clinical safety of TGP adjuvant therapy in the RA treatment. Methods PubMed, EMBASE, Web of Science, China Network Knowledge Infrastructure (CNKI), SinoMed and WanFang Data were retrieved for randomized controlled trials (RCTs) and cohort study about TGP adjuvant therapy in patients with RA up to 28 January 2021. Literatures with eligibility criteria and information were screened and extracted by two researchers independently. The RevMan5.3 software was used for data analysis with effect estimates as risk ratio (RR) with 95% confidence interval (CI). Results A total of 39 studies involving 3680 RA participants were included. There were 8 comparisons: TGP plus methotrexate (MTX) therapy versus MTX therapy, TGP plus leflunomide (LEF) therapy versus LEF therapy, TGP plus MTX and LEF therapy versus MTX plus LEF therapy, TGP plus tripterygium glycosides (TG) therapy versus TG therapy, TGP plus meloxicam (MLX) therapy versus MLX therapy and TGP plus sulfasalazine (SSZ) therapy versus SSZ therapy, TGP plus iguratimod (IGU) therapy versus IGU therapy, TGP plus prednisone acetate tablets (PAT) therapy versus PAT therapy. The meta-analysis results showed that the occurrence of hepatic adverse effect (RR = 0.31, 95% CI = 0.23–0.41, P < 0.00001) and leukopenia (RR = 0.41, 95% CI = 0.26–0.66, P = 0.0002) in TGP adjuvant therapy was significant decreased compared with non-TGP therapy. However, only TGP plus LEF therapy (RR = 0.22, 95% CI = 0.08–0.60, P = 0.003) and TGP plus MTX and LEF therapy (RR = 0.31, 95% CI = 0.22–0.42, P < 0.00001) had statistical difference in the subgroups of hepatic adverse effect. In leukopenia, TGP plus MTX and LEF therapy (RR = 0.47, 95% CI = 0.25–0.87, P = 0.02) had statistical difference. Conclusions This meta-analysis indicated that TGP adjuvant therapy might alleviate the incidence of hepatic adverse effect and leukopenia for the RA treatment compared to non-TGP therapy. The clinical safety of TGP adjuvant therapy warrant further investigation in experimental studies.


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