Trends in recruitment of women and reporting of sex differences in large-scale published randomized controlled trials in stroke

2019 ◽  
Vol 14 (9) ◽  
pp. 931-938 ◽  
Author(s):  
Cheryl Carcel ◽  
Mark Woodward ◽  
Grace Balicki ◽  
Georgia Louise Koroneos ◽  
Diana Aguiar de Sousa ◽  
...  
Keyword(s):  
Sex Differences ◽  
Randomized Controlled Trials ◽  
North American ◽  
Large Scale ◽  
Implementation Strategies ◽  
Therapeutic Interventions ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Time Period ◽  
Key Stakeholders

Background Understanding of sex differences, especially in terms of the influence of sex on therapeutic interventions, can lead to improved treatment and management for all. Aim We examined temporal and regional trends in female participation and the reporting of sex differences in stroke randomized controlled trials. Methods Randomized controlled trials from 1990 to 2018 were identified from ClinicalTrials.gov, using keywords “stroke” and “cerebrovascular accidents.” Studies were selected if they enrolled ≥100 participants, included both sexes and were published trials (identified using PubMed, Google Scholar, and Scopus). Results Of 1700 stroke randomized controlled trials identified, 277 were published and eligible for analysis. Overall, these randomized controlled trials enrolled only 40% females, and in the past 10 years, this percentage barely changed, peaking at 41% in 2008–2009 and 2012–2013. North American randomized controlled trials recruited the most women, at 43%, and Asia the lowest, at 40%. Among the 277 randomized controlled trials, 101 (36%) reported results according to sex, of which 91 (33%) were pre-specified analyses. The increasing trend in the number of studies reporting sex-differentiated results from 2008 to 2018 merely paralleled the increase in the number of papers published during the same time period. North American randomized controlled trials most often reported sex-specific results (42%), and Australia and Europe least often (31%). Conclusion Little progress has been made in the inclusion of females and the reporting of sex in stroke randomized controlled trials. This highlights the need for key stakeholders, such as funders and journal editors, to provide clear guidance and effective implementation strategies to researchers in the scientific reporting of sex.

Effects of Dingchuan Decoction on Lung Function and Clinical Effectiveness Rate in Children with Asthma: A Systematic Review and Meta-Analysis

2021 ◽  
pp. 1-12
Author(s):  
Sheng-Nan Wang ◽  
Jia-Li Yan ◽  
Shao-Xing Wu ◽  
Lei Wu ◽  
Yan-Chan Zheng ◽  
...  
Keyword(s):  
Lung Function ◽  
Randomized Controlled Trials ◽  
Large Scale ◽  
Clinical Effectiveness ◽  
Controlled Trials ◽  
Improvement Rate ◽  
Randomized Controlled ◽  
Conventional Medication ◽  
Effectiveness Rate ◽  
Children With Asthma

Dingchuan decoction (DCD) is a traditional Chinese prescription for asthma that remains popular today. To systematically evaluate the effect of DCD on lung function, clinical effectiveness rate, and safety in children with asthma, significant databases were searched for randomized controlled trials from their inception to September 9, 2019. Randomized controlled trials assessing the effect of DCD on lung function and clinical effectiveness rate in children with asthma were included in this meta-analysis. The methodological quality of the included trials was assessed using the Cochrane risk of bias tool. RevMan 5.3 was used for data analysis. Fourteen studies with 1,384 children were reviewed. FEV<sub>1</sub> improvement rate (mean difference [MD] 12.50, 95% confidence interval [CI] 8.72–16.29), PEF improvement rate (MD 14.28, 95% CI 11.08–17.49), and clinical effectiveness rate (relative risk 1.19, 95% CI 1.14–1.25) significantly increased in the DCD group when compared to simple conventional medication. Four trials suggest that DCD is safe for children. In conclusion, the use of DCD combined with conventional medication improves lung function and clinical effectiveness rate better than simple conventional medication. However, the selected trials lack blinding and large-scale studies. Therefore, to better manage DCD in clinical practice, more randomized controlled trials and large-scale studies are required for further evaluation.

Efficacy and tolerability of Lavandula angustifolia in treating patients with the diagnosis of depression: a systematic review of randomized controlled trials

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Ahmad Shamabadi ◽  
Shahin Akhondzadeh
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Large Scale ◽  
Primary Outcome ◽  
Controlled Trials ◽  
Lavandula Angustifolia ◽  
Randomized Controlled ◽  
Depressed Patients ◽  
Antidepressant Effects ◽  
And Control

Abstract Pharmacotherapy is the conventional treatment for depression, with only half of the patients responding to the first trial of monotherapy with first-line medicines. One way to overcome this resistance is to use complementary and alternative medicine. The antidepressant effects of Lavandula angustifolia, which is commonly called lavender, have been investigated in previous studies. This study aims to provide the first systematic review of lavender in treating patients with depression diagnosis. ISI Web of Science, Scopus, PubMed, Embase, PsycINFO, Google Scholar, and three trial registries were searched until May 2020 to find randomized controlled trials on lavender for depressed patients. The primary outcome was difference between the intervention and control groups in changing depression scores from baseline to endpoint. The included studies were assessed for effect size and methodological quality. Seven clinical trials were identified, in which 852 patients were studied. In six trials, the effectiveness of lavender in treating depression was reported, as being more pronounced adjunct to a typical antidepressant in one study. Significant reported side effects include headaches and eructation. Lavender is beneficial, tolerable, and safe in treating depression. Despite obtaining promising results, they are not enough to recommend prescribing lavender to depressed patients. Further high-quality, large-scale studies for rectifying the shortcomings of existing studies are recommended.

Noninvasive Brain Stimulation for Poststroke Dysphagia: A Meta-Analysis for Randomized Controlled Trials

2021 ◽  
pp. 1-8
Author(s):  
Yixin Zhu ◽  
Lihua Gu
Keyword(s):  
Motor Cortex ◽  
Randomized Controlled Trials ◽  
Large Scale ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Swallowing Function ◽  
Swallowing Therapy ◽  
Randomized Controlled ◽  
Therapy Effect

<b><i>Background:</i></b> Past research has indicated that repetitive transcranial magnetic stimulation (rTMS) on the pharyngeal motor cortex may be beneficial to poststroke dysphagic patients. In addition, some studies have supported that transcranial direct current stimulation (tDCS) over the pharyngeal motor cortex can improve swallowing function in poststroke dysphagia. However, some studies showed that rTMS and tDCS show no effect on poststroke dysphagia. This study aims to make a meta-analysis to investigate the therapy effect of rTMS and tDCS on poststroke dysphagia in randomized controlled trials (RCTs). <b><i>Methods:</i></b> We searched for studies published before March 2021 in databases (PubMed, Web of Science, MEDLINE, EMBASE, and Google Scholar). Meta-analysis was made to compute the results of included studies using STATA 12.0 software. <b><i>Results:</i></b> The present study shows a significant increase in the swallowing function in poststroke dysphagia given rTMS compared to those given sham rTMS (standardized mean difference [SMD] = 1.08, 95% confidence interval [CI] = 0.37–1.80, <i>I</i><sup>2</sup> = 81.2%, <i>p</i> &#x3c; 0.001). In addition, the study shows a significant increase in the swallowing function in poststroke dysphagia given tDCS (combined or not combined with conventional swallowing therapy), compared to those given sham tDCS (combined or not combined with conventional swallowing therapy) (SMD = 1.43, 95% CI = 0.73–2.13, <i>I</i><sup>2</sup> = 77.6%, <i>p</i> &#x3c; 0.001). <b><i>Conclusions:</i></b> The study demonstrates that rTMS and tDCS over the pharyngeal motor cortex show therapy effects on poststroke dysphagia. Many more large-scale, blinded RCTs are essential to investigate the effect of rTMS and tDCS on poststroke dysphagia.

scholarly journals SGLT 2 INHIBITORS: NEWER PARADIGMS IN THE TREATMENT OF HEART FAILURE WITH REDUCED EJECTION FRACTION

2021 ◽  
Vol 9 (11) ◽  
pp. 1043-1046
Author(s):  
Shaista Alvi
Keyword(s):  
Diabetes Mellitus ◽  
Heart Failure ◽  
Ejection Fraction ◽  
Randomized Controlled Trials ◽  
Large Scale ◽  
Controlled Trials ◽  
Reduced Ejection Fraction ◽  
Randomized Controlled

Heart Failure is a growing concern now a days. Many drugs are available for the treatment of heart failure but still there is increasing prevalence of heart failure. SGLT 2 inhibitors were initially developed for diabetes mellitus but they are found to be effective for Heart Failure with reduced ejection also. Many large scale randomized controlled trials also confirmed this and now they are recommended in the treatment of heart failure with reduced ejection fraction.

scholarly journals The Effect of Acupuncture in Breast Cancer–Related Lymphoedema (BCRL): A Systematic Review and Meta-Analysis

2019 ◽  
Vol 18 ◽  
pp. 153473541986691 ◽  
Author(s):  
Tsai-Ju Chien ◽  
Chia-Yu Liu ◽  
Ching-Ju Fang
Keyword(s):  
Breast Cancer ◽  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Large Scale ◽  
Meta Analysis ◽  
Lymphatic Drainage ◽  
Controlled Trials ◽  
Breast Cancer Patients ◽  
Eligibility Criteria ◽  
Randomized Controlled

Background: Breast cancer–related lymphedema (BCRL) is hard to control. Management may include lymphatic drainage, skin care, bandaging, or even surgery. Since acupuncture has been proven to affect the neurophysiology and neuroendocrine systems, it has the potential to control BCRL. Aim: To evaluate the effect of acupuncture in BCRL in randomized controlled trials. Design: A literature search was performed, following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement and without language restrictions. Data Sources: Five databases were searched from inception tthrough September 2018. Only studies that fulfilled the eligibility criteria of evaluating the effect of acupuncture on lymphedema in breast cancer were included. The methodological quality of these trials was assessed using the Cochrane criteria, and meta-analysis software (RevMan 5.3) was used for analysis. Results: We examined 178 breast cancer patients from 6 trials. All included randomized controlled trials had medium to high quality, based on the modified Jadad scale. The systematic review showed that acupuncture is safe and has a trend to improve symptoms, but trials did not consistently measure outcomes. The meta-analysis showed that acupuncture produced no significant improvement in the extent of lymphedema as compared with the control intervention (−1.90; 95% confidence interval = −5.39 to 1.59, P = .29). None of the studies reported severe adverse events. Conclusions: Acupuncture is safe and has a trend to improve the lymphedema related to breast cancer, yet it did not significantly change arm circumference in BCRL. Future studies should include both subjective and objective measurements and large-scale studies are warranted.

scholarly journals From Proof of Concept to Scalable Policies: Challenges and Solutions, with an Application

2017 ◽  
Vol 31 (4) ◽  
pp. 73-102 ◽  
Author(s):  
Abhijit Banerjee ◽  
Rukmini Banerji ◽  
James Berry ◽  
Esther Duflo ◽  
Harini Kannan ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Large Scale ◽  
Fine Tuning ◽  
Controlled Trials ◽  
Proof Of Concept ◽  
Government Schools ◽  
Randomized Controlled ◽  
Randomized Control ◽  
The Right ◽  
Actual Learning

The promise of randomized controlled trials is that evidence gathered through the evaluation of a specific program helps us—possibly after several rounds of fine-tuning and multiple replications in different contexts—to inform policy. However, critics have pointed out that a potential constraint in this agenda is that results from small “proof-of-concept” studies run by nongovernment organizations may not apply to policies that can be implemented by governments on a large scale. After discussing the potential issues, this paper describes the journey from the original concept to the design and evaluation of scalable policy. We do so by evaluating a series of strategies that aim to integrate the nongovernment organization Pratham’s “Teaching at the Right Level” methodology into elementary schools in India. The methodology consists of reorganizing instruction based on children’s actual learning levels, rather than on a prescribed syllabus, and has previously been shown to be very effective when properly implemented. We present evidence from randomized controlled trials involving some designs that failed to produce impacts within the regular schooling system but still helped shape subsequent versions of the program. As a result of this process, two versions of the programs were developed that successfully raised children’s learning levels using scalable models in government schools. We use this example to draw general lessons about using randomized control trials to design scalable policies.

Psychotherapy for Psychopathology During Pregnancy and the Postpartum Period

2015 ◽  
Author(s):  
Amy Wenzel ◽  
Scott Stuart ◽  
Hristina Koleva
Keyword(s):  
Randomized Controlled Trials ◽  
Large Scale ◽  
Behavioral Therapy ◽  
Treatment Retention ◽  
Future Research ◽  
Controlled Trials ◽  
Depression And Anxiety ◽  
Randomized Controlled ◽  
Medication Exposure ◽  
Perinatal Women

Psychotherapy is often the treatment of choice for perinatal women who wish to limit their fetus’s or infant’s medication exposure. The vast majority of empirical research that has examined psychotherapy for perinatal women has focused on depression. Interpersonal psychotherapy (IPT) and cognitive behavioral therapy (CBT) have been examined in several studies to determine their efficacy in perinatal depression and anxiety. Recent research has begun to examine the manner in which psychotherapies can be delivered in alternative formats (e.g., teletherapy) in order to overcome problems with treatment retention and compliance. Suggestions for future research include large-scale randomized controlled trials that compare two active approaches to psychotherapy, mediation studies to uncover the mechanisms of change associated with the successful treatment of perinatal women, and randomized controlled trials evaluating the efficacy of psychotherapy for mental health disorders other than depression.

scholarly journals Systematic Review and Meta-Analysis of Randomized Controlled Trials of Xingnaojing Treatment for Stroke

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Weijun Peng ◽  
Jingjing Yang ◽  
Yang Wang ◽  
Weihao Wang ◽  
Jianxia Xu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Conventional Treatment ◽  
Large Scale ◽  
Data Extraction ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Study Selection ◽  
Mild Impairment

Objective. Xingnaojing injection (XNJ) is a well-known traditional Chinese patent medicine (TCPM) for stroke. The aim of this study is to assess the efficacy of XNJ for stroke including ischemic stroke, intracerebral hemorrhage (ICH), and subarachnoid hemorrhage (SAH).Methods. An extensive search was performed within using eight databases up to November 2013. Randomized controlled trials (RCTs) on XNJ for treatment of stroke were collected. Study selection, data extraction, quality assessment, and meta-analysis were conducted according to the Cochrane standards, and RevMan5.0 was used for meta-analysis.Results. This review included 13 RCTs and a total of 1,514 subjects. The overall methodological quality was poor. The meta-analysis showed that XNJ combined with conventional treatment was more effective for total efficacy, neurological deficit improvement, and reduction of TNF-αlevels compared with those of conventional treatment alone. Three trials reported adverse events, of these one trial reported mild impairment of kidney and liver function, whereas the other two studies failed to report specific adverse events.Conclusion. Despite the limitations of this review, we suggest that XNJ in combination with conventional medicines might be beneficial for the treatment of stroke. Currently there are various methodological problems in the studies. Therefore, high-quality, large-scale RCTs are urgently needed.

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