scholarly journals A living systematic review protocol for COVID-19 clinical trial registrations

2020 ◽  
Vol 5 ◽  
pp. 60 ◽  
Author(s):  
Brittany J. Maguire ◽  
Philippe J. Guérin
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Geographic Location ◽  
Diagnostic Methods ◽  
Future Research ◽  
Strong Response ◽  
Level Of Evidence

Since the coronavirus disease 2019 (COVID-19) outbreak was identified in December 2019 in Wuhan, China, a strong response from the research community has been observed with the proliferation of independent clinical trials assessing diagnostic methods, therapeutic and prophylactic strategies. While there is no intervention for the prevention or treatment of COVID-19 with proven clinical efficacy to date, tools to distil the current research landscape by intervention, level of evidence and those studies likely powered to address future research questions is essential. This living systematic review aims to provide an open, accessible and frequently updated resource summarising the characteristics of COVID-19 clinical trial registrations. Weekly search updates of the WHO International Clinical Trials Registry Platform (ICTRP) and source registries will be conducted. Data extraction by two independent reviewers of trial characteristic variables including categorisation of trial design, geographic location, intervention type and targets, level of evidence and intervention adaptability to low resource settings will be completed. Descriptive and thematic synthesis will be conducted. A searchable and interactive visualisation of the results database will be created, and made openly available online. Weekly results from the continued search updates will be published and made available on the Infectious Diseases Data Observatory (IDDO) website (COVID-19 website). This living systematic review will provide a useful resource of COVID-19 clinical trial registrations for researchers in a rapidly evolving context. In the future, this sustained review will allow prioritisation of research targets for individual patient data meta-analysis.

scholarly journals Acupuncture for Managing Cancer-Related Insomnia: A Systematic Review of Randomized Clinical Trials

2016 ◽  
Vol 16 (2) ◽  
pp. 135-146 ◽  
Author(s):  
Tae-Young Choi ◽  
Jong In Kim ◽  
Hyun-Ja Lim ◽  
Myeong Soo Lee
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Sleep Quality ◽  
Randomized Clinical Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Sham Acupuncture ◽  
Risk Of Bias ◽  
The Other ◽  
Level Of Evidence

Background. Insomnia is a prominent complaint of cancer patients that can significantly affect their quality of life and symptoms related to sleep quality. Conventional drug approaches have a low rate of success in alleviating those suffering insomnia. The aim of this systematic review was to assess the efficacy of acupuncture in the management of cancer-related insomnia. Methods. A total of 12 databases were searched from their inception through January 2016 without language restriction. Randomized controlled trials (RCTs) and quasi-RCTs were included if acupuncture was used as the sole intervention or as an adjunct to another standard treatment for any cancer-related insomnia. The data extraction and the risk of bias assessments were performed by 2 independent reviewers. Results. Of the 90 studies screened, 6 RCTs were included. The risk of bias was generally unclear or low. Three RCTs showed equivalent effects on the Pittsburgh Sleep Quality Index and 2 RCTs showed the similar effects on response rate to those of conventional drugs at the end of treatment. The other RCT showed acupuncture was better than hormone therapy in the numbers of hours slept each night and number of times woken up each night. The 3 weeks of follow-up in 2 RCTs showed superior effects of acupuncture compared with conventional drugs, and a meta-analysis showed significant effects of acupuncture. Two RCTs tested the effects of acupuncture on cancer-related insomnia compared with sham acupuncture. One RCT showed favourable effects, while the other trial failed to do so. Conclusion. There is a low level of evidence that acupuncture may be superior to sham acupuncture, drugs or hormones therapy. However, the number of studies and effect size are small for clinical significance. Further clinical trials are warranted.

scholarly journals Are digital technology interventions effective to reduce loneliness in older adults? A systematic review and meta-analysis

2020 ◽  
Author(s):  
Syed Ghulam Sarwar Shah ◽  
David Nogueras ◽  
Hugo Cornelis van Woerden ◽  
Vasiliki Kiparoglou
Keyword(s):  
Systematic Review ◽  
Older Adults ◽  
Clinical Trials ◽  
English Language ◽  
Data Extraction ◽  
Meta Analysis ◽  
Future Research ◽  
Before And After ◽  
Quasi Experimental

Objective: To review the latest literature on the effectiveness of DTIs in reducing loneliness in (older) adults. Data Sources: Electronic searches in PubMed, Medline, CINAHL, EMBASE and Web of Science covering publication period from 1 January 2010 to 31 July 2019. Subjects: Adult men and women Design: Systematic review and meta-analysis Main Outcome Measure: Loneliness. Study Selection: Primary studies that used DTIs for tackling loneliness in adults (aged ≥18 years) with follow-up measurements at least three months or more and publication in the English language. Data Extraction and Synthesis: Two researchers independently screened articles and extracted data on several variables: participants, interventions, comparators and outcomes. Data was extracted on the primary outcome i.e. loneliness measured at the baseline and follow-up measurements at three, four, six and twelve months after the intervention. Results: Six studies were selected from 4939 articles screened. Selected studies included 5 clinical trials (4 RCTs and 1 quasi experimental study) and one before and after study, which enrolled 646 participants (men =154 (24%), women =427 (66%), no gender information =65 (10%) with average age between 73 and 78 years (SD 6-11). Five clinical trials were included in the meta-analysis and standardised mean differences (SMD) were calculated for each trial and pooled across studies using a random effects model. The overall effect estimates were not statistically significant in follow-up measurements at three months (SMD= 0.02, 95% CI= -0.36, 0.40; P=0.92), four months (SMDs= -1.11, 95% CI= -2.60, 0.38; P=0.14) and six months (SMD= -0.11, 95% CI= -0.54, 0.32; P=0.61). The quality of evidence was very low to moderate in these trials. Conclusions: There is insufficient evidence to make conclusions that DTIs are effective in reducing loneliness in older adults. Future research may consider RCTs with larger sample sizes and longer duration of interventions and follow-up.

scholarly journals Defining Optimal Dosing of Nimodipine in Aneurysmal Subarachnoid Hemorrhage: Study Protocol for a Systematic Review

2020 ◽  
Author(s):  
judith bellapart ◽  
Kevin B Laupland ◽  
Eva Malacova ◽  
Jeffrey Lipman ◽  
Jason A Roberts ◽  
...  
Keyword(s):  
Systematic Review ◽  
Subarachnoid Hemorrhage ◽  
Cerebral Vasospasm ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Data Extraction ◽  
Meta Analysis ◽  
Future Research ◽  
Level Of Evidence ◽  
Optimal Dosing ◽  
Clinical Scenarios

Abstract Background: Nimodipine has been first line prophylaxis of cerebral vasospasm after subarachnoid hemorrhage for more than three decades, but its level of evidence has become controversial and essential questions regarding its pharmacological properties and its precise mechanism of action remain unclear. The level of evidence for Nimodipine was established in times when subarachnoid hemorrhage patients had their aneurysm secured in a delayed phase and when intravascular coiling was not established, these two clinical scenarios differ from current practice questioning the applicability of its therapeutic regimen. This review aims to investigate the strength of nimodipine as a prophylaxis for cerebral vasospasm within a contemporary context and to propose pathways for future research in nimodipine. Methods: We will search electronic databases including Medline, Embase, Cochrane, Web of Science and PubMed using a defined search strategy. Two authors will independently rate the quality of the searched evidence using the Chalmers scale for the scoring of studies ‘quality. Discrepancies will be assessed by a third independent author. All studies will be described in a table of studies’ characteristics and data extraction completed. Meta-analysis will be performed if there are two or greater homogeneous outcomes that suffices for reporting on measures of variability. Discussion: The results rising from this systematic review may guide further clinical trials focused on nimodipine dosing with the view of optimizing therapy for better neurological outcomes.Systematic review registration: PROSPERO ID = CRD42020188319

scholarly journals Effects of open-label placebos in clinical trials: a systematic review and meta-analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Melina von Wernsdorff ◽  
Martin Loef ◽  
Brunna Tuschen-Caffier ◽  
Stefan Schmidt
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Medical Condition ◽  
Data Extraction ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Open Label ◽  
Cancer Related Fatigue ◽  
Promising Treatment ◽  
Irritable Bowel

AbstractOpen-label placebos (OLPs) are placebos without deception in the sense that patients know that they are receiving a placebo. The objective of our study is to systematically review and analyze the effect of OLPs in comparison to no treatment in clinical trials. A systematic literature search was carried out in February 2020. Randomized controlled trials of any medical condition or mental disorder comparing OLPs to no treatment were included. Data extraction and risk of bias rating were independently assessed. 1246 records were screened and thirteen studies were included into the systematic review. Eleven trials were eligible for meta-analysis. These trials assessed effects of OLPs on back pain, cancer-related fatigue, attention deficit hyperactivity disorder, allergic rhinitis, major depression, irritable bowel syndrome and menopausal hot flushes. Risk of bias was moderate among all studies. We found a significant overall effect (standardized mean difference = 0.72, 95% Cl 0.39–1.05, p < 0.0001, I2 = 76%) of OLP. Thus, OLPs appear to be a promising treatment in different conditions but the respective research is in its infancy. More research is needed, especially with respect to different medical and mental disorders and instructions accompanying the OLP administration as well as the role of expectations and mindsets.

scholarly journals Clinical effectiveness of convalescent plasma in hospitalized patients with COVID-19: a systematic review and meta-analysis

2021 ◽  
Vol 15 ◽  
pp. 175346662110280
Author(s):  
Roberto Ariel Abeldaño Zuñiga ◽  
Ruth Ana María González-Villoria ◽  
María Vanesa Elizondo ◽  
Anel Yaneli Nicolás Osorio ◽  
David Gómez Martínez ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Clinical Improvement ◽  
Data Extraction ◽  
Meta Analysis ◽  
Clinical Effectiveness ◽  
Risk Of Bias ◽  
Hospitalized Patients ◽  
Low Risk ◽  
Controlled Clinical Trials

Aims: Given the variability of previously reported results, this systematic review aims to determine the clinical effectiveness of convalescent plasma employed in the treatment of hospitalized patients diagnosed with COVID-19. Methods: We conducted a systematic review of controlled clinical trials assessing treatment with convalescent plasma for hospitalized patients diagnosed with SARS-CoV-2 infection. The outcomes were mortality, clinical improvement, and ventilation requirement. Results: A total of 51 studies were retrieved from the databases. Five articles were finally included in the data extraction and qualitative and quantitative synthesis of results. The overall risk of bias in the reviewed articles was established at low-risk only in two trials. The meta-analysis suggests that there is no benefit of convalescent plasma compared with standard care or placebo in reducing the overall mortality and the ventilation requirement. However, there could be a benefit for the clinical improvement in patients treated with plasma. Conclusion: Current results led to assume that the convalescent plasma transfusion cannot reduce the mortality or ventilation requirement in hospitalized patients diagnosed with SARS-CoV-2 infection. More controlled clinical trials conducted with methodologies that ensure a low risk of bias are still needed. The reviews of this paper are available via the supplemental material section.

scholarly journals Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis

BMJ ◽  
2018 ◽  
pp. k4738 ◽  
Author(s):  
Joanna C Crocker ◽  
Ignacio Ricci-Cabello ◽  
Adwoa Parker ◽  
Jennifer A Hirst ◽  
Alan Chant ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Lived Experience ◽  
Odds Ratio ◽  
Public Involvement ◽  
Meta Analysis ◽  
Patient And Public Involvement ◽  
Retention Rates ◽  
The Impact

AbstractObjectiveTo investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI.DesignSystematic review and meta-analysis.Data sourcesTen electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries.Eligibility criteriaExperimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement).Data extraction and analysisTwo independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses.Results26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14v1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95% confidence interval 0.33 to 4.14), for main analysis).ConclusionsThese findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention.Systematic review registrationPROSPERO CRD42016043808.

Therapeutic efficacy of specific immunotherapy for glioma: a systematic review and meta-analysis

2018 ◽  
Vol 29 (4) ◽  
pp. 443-461 ◽  
Author(s):  
Sara Hanaei ◽  
Khashayar Afshari ◽  
Armin Hirbod-Mobarakeh ◽  
Bahram Mohajer ◽  
Delara Amir Dastmalchi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Overall Survival ◽  
Clinical Trials ◽  
Specific Immunotherapy ◽  
Data Extraction ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Control Group ◽  
Free Survival ◽  
Median Difference

Abstract Although different immunotherapeutic approaches have been developed for the treatment of glioma, there is a discrepancy between clinical trials limiting their approval as common treatment. So, the current systematic review and meta-analysis were conducted to assess survival and clinical response of specific immunotherapy in patients with glioma. Generally, seven databases were searched to find eligible studies. Controlled clinical trials investigating the efficacy of specific immunotherapy in glioma were found eligible. After data extraction and risk of bias assessment, the data were analyzed based on the level of heterogeneity. Overall, 25 articles with 2964 patients were included. Generally, mean overall survival did not statistically improve in immunotherapy [median difference=1.51; 95% confidence interval (CI)=−0.16–3.17; p=0.08]; however, it was 11.16 months higher in passive immunotherapy (95% CI=5.69–16.64; p<0.0001). One-year overall survival was significantly higher in immunotherapy groups [hazard ratio (HR)=0.69; 95% CI=0.52–0.92; p=0.01]. As the hazard rate in the immunotherapy approach was 0.83 of the control group, 2-year overall survival was significantly higher in immunotherapy (HR=0.83; 95% CI=0.69–0.99; p=0.04). Three-year overall survival was significantly higher in immunotherapy as well (HR=0.67; 95% CI=0.48–0.92; p=0.01). Overall, median progression-free survival was significantly higher in immunotherapy (standard median difference=0.323; 95% CI=0.110–0.536; p=0.003). However, 1-year progression-free survival was not remarkably different between immunotherapy and control groups (HR=0.94; 95% CI=0.74–1.18; p=0.59). Specific immunotherapy demonstrated remarkable improvement in survival of patients with glioma and could be a considerable choice of treatment in the future. Despite the current promising results, further high-quality randomized controlled trials are required to approve immunotherapeutic approaches as the standard of care and the front-line treatment for glioma.

scholarly journals Effects of Aerobic Training Progression on Blood Pressure in Individuals With Hypertension: A Systematic Review With Meta-Analysis and Meta-Regression

2021 ◽  
Author(s):  
Guilherme Tadeu de Barcelos¹ ◽  
Isabel Heberle¹ ◽  
Juliana Cavestré Coneglian¹ ◽  
Bruno Allan Vieira¹ ◽  
Rodrigo Sudatti Delevatti¹ ◽  
...  
Keyword(s):  
Systematic Review ◽  
Blood Pressure ◽  
Clinical Trials ◽  
Systolic Blood Pressure ◽  
Aerobic Training ◽  
Data Extraction ◽  
Meta Analysis ◽  
Control Group ◽  
Meta Regression ◽  
Selection Of

Abstract Objective: To analyze, through a systematic review with meta-analysis, the effects of aerobic training with and without progression on systolic blood pressure (SBP) and diastolic blood pressure (DBP) in hypertensive adults.Method: The search for the studies was carried out in the PubMed, Cochrane Central, SPORTDiscus and LILACS databases. Clinical trials that analyzed the effect of aerobic training, lasting at least six weeks, on blood pressure in hypertensive individuals comparing with a control group without intervention were selected. The selection of studies and data extraction were carried out independently by two pairs of researchers. Results: Of the 13028 studies found, 24 were selected and included in this review. There was a reduction in SBP after aerobic training with progression (-10.67 mmHg; 95% CI -15.421, -5.926; p <0.001) and without progression (-10.17 mmHg; CI -12.213, -8.120; p <0.001). DBP also decreased after aerobic training with progression (-5.49 mmHg; 95% CI -8.663, -2.310; p <0.001) and without progression (-6.51 mmHg; 95% CI -9.147, -3.868; p < 0.001). Conclusion: Aerobic training promotes a reduction in the SBP and DBP levels of adults with hypertension, regardless of whether or not the training variables progression.

scholarly journals A Systematic Review of the Contribution of Dance Movement Psychotherapy Towards the Well-Being of Children With Autism Spectrum Disorders

2021 ◽  
Vol 12 ◽  
Author(s):  
Supritha Aithal ◽  
Zoe Moula ◽  
Vicky Karkou ◽  
Themis Karaminis ◽  
Joanne Powell ◽  
...  
Keyword(s):  
Systematic Review ◽  
Mixed Methods ◽  
Large Scale ◽  
Data Extraction ◽  
Meta Analysis ◽  
Well Being ◽  
Autism Spectrum ◽  
Level Of Evidence ◽  
Dance Movement ◽  
Protocol Registration

Background: The present review provides an original examination of published literature on the use of Dance Movement Psychotherapy (DMP) as an intervention for children with an Autism Spectrum Disorder (ASD).Method: The review was systematically conducted using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. A protocol consisting of four phases: identification; screening and selection; data extraction and synthesis; quality assurance was developed and registered with the PROSPERO. A search strategy was developed using population and intervention as the key concepts and ten databases were searched between 6.1.2018 to 4.4.2018 and 10.07.2021 to 20.07.2021. The intervention characteristics were extracted based on the TIDieR template for intervention description and replication checklist. Quality assessment and level of evidence of all the included studies were evaluated using the Mixed Methods Appraisal Tool (MMAT) and the Centre for Evidence-Based Medicine (CEBM) for treatment criteria.Results: Nine research studies with a total of 133 participants were identified through a systematic search process. There was only one mixed-methods study with the component of randomisation found during the literature search. Collected information was synthesised in relation to (a) ways in which dance movement psychotherapists work with children; (b) data collection methods and findings. Results from the reviewed literature suggest that DMP can potentially promote various aspects of well-being in children with ASD. Eight out of nine studies mentioned the effects of DMP on improving different social and communication skills. However, results from quality assessments and synthesised outcomes indicate that research in DMP is still in its infancy.Conclusions: We conclude that further large-scale, high-quality studies are required to generate further evidence that explains the processes involved in DMP, the effectiveness of DMP, the relationship between therapeutic factors of DMP, and research findings for children on the autism spectrum.Systematic Review Protocol Registration: PROSPERO, identifier: CRD42018087912.

scholarly journals Ultrasound measurement of brain tissue movement in humans: A systematic review

Ultrasound ◽  
2019 ◽  
Vol 28 (2) ◽  
pp. 70-81 ◽  
Author(s):  
Jonathan Ince ◽  
Meshal Alharbi ◽  
Jatinder S Minhas ◽  
Emma ML Chung
Keyword(s):  
Systematic Review ◽  
Brain Tissue ◽  
Data Extraction ◽  
Evidence Synthesis ◽  
Meta Analysis ◽  
Qualitative Evaluation ◽  
Health Conditions ◽  
Ultrasound Measurement ◽  
Future Research ◽  
Tissue Motion

Introduction It has long been suggested that ultrasound could be used to measure brain tissue pulsations in humans, but potential clinical applications are relatively unexplored. The aim of this systematic review was to explore and synthesise available literature on ultrasound measurement of brain tissue motion in humans. Methods Our systematic review was designed to include predefined study selection criteria, quality evaluation, and a data extraction pro-forma, registered prospectively on PROSPERO (CRD42018114117). The systematic review was conducted by two independent reviewers. Results Ten studies were eligible for the evidence synthesis and qualitative evaluation. All eligible studies confirmed that brain tissue motion over the cardiac cycle could be measured using ultrasound; however, data acquisition, analysis, and outcomes varied. The majority of studies used tissue pulsatility imaging, with the right temporal window as the acquisition point. Currently available literature is largely exploratory, with measurements of brain tissue displacement over a narrow range of health conditions and ages. Explored health conditions include orthostatic hypotension and depression. Conclusion Further studies are needed to assess variability in brain tissue motion estimates across larger cohorts of healthy subjects and in patients with various medical conditions. This would be important for informing sample size estimates to ensure future studies are appropriately powered. Future research would also benefit from a consistent framework for data analysis and reporting, to facilitate comparative research and meta-analysis. Following standardisation and further healthy participant studies, future work should focus on assessing the clinical utility of brain tissue pulsation measurements in cerebrovascular disease states.

Sign in / Sign up

Export Citation Format

Share Document