scholarly journals Typology of the Primary Outcome Construction in Dermatology: A Systematic Review of Published Randomized Controlled Trials

2013 ◽  
Vol 133 (2) ◽  
pp. 371-376 ◽  
Author(s):  
Dany Nassar ◽  
Emilie Sbidian ◽  
Sylvie Bastuji-Garin ◽  
Ludovic Martin ◽  
Alain Dupuy
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Primary Outcome ◽  
Controlled Trials ◽  
Randomized Controlled

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.

scholarly journals The Effect of Exercise on Cancer-Related Cognitive Impairment and Applications for Physical Therapy: Systematic Review of Randomized Controlled Trials

2020 ◽  
Vol 100 (3) ◽  
pp. 523-542 ◽  
Author(s):  
Kristin L Campbell ◽  
Kendra Zadravec ◽  
Kelcey A Bland ◽  
Elizabeth Chesley ◽  
Florian Wolf ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cognitive Impairment ◽  
Cognitive Function ◽  
Randomized Controlled Trials ◽  
Primary Outcome ◽  
Cognitive Impairments ◽  
Common Side Effect ◽  
Future Research ◽  
Controlled Trials ◽  
Randomized Controlled

Abstract Background Cancer-related cognitive impairment (CRCI), often called “chemo-brain” or “chemo-fog,” is a common side effect among adults with cancer, which can persist well after treatment completion. Accumulating evidence demonstrates exercise can improve cognitive function in healthy older adults and adults with cognitive impairments, suggesting exercise may play a role in managing CRCI. Purpose The purpose was to perform a systematic review of randomized controlled trials (RCTs) to understand the effect of exercise on CRCI. Data Sources Relevant literature was retrieved from CINAHL, Medline (Ovid), and EMBASE. Study Selection Eligible articles were RCTs that prescribed aerobic, resistance, combined aerobic/resistance, or mind-body (eg, yoga or Qigong) exercise during or following cancer treatment and included cognitive function outcome measures. Data Extraction Descriptive information and Cohen d effect sizes were directly extracted or calculated for included trials. Data Synthesis Twenty-nine trials were included in the final analysis. A statistically significant effect of exercise on self-reported cognitive function, both during and postadjuvant treatment, was reported in 12 trials (41%) (Cohen d range: 0.24–1.14), most commonly using the EORTC QLQ-C30. Ten trials (34%) performed neuropsychological testing to evaluate cognitive function; however, only 3 trials in women with breast cancer reported a significant effect of exercise (Cohen d range: 0.41–1.47). Limitations Few RCTs to date have evaluated the effect of exercise on CRCI as a primary outcome. Twenty-six trials (90%) in this review evaluated CRCI as secondary analyses. Conclusions Evidence supporting exercise as a strategy to address CRCI is limited. Future research evaluating CRCI as a primary outcome, including self-reported and objective measures, is needed to confirm the possible role of exercise in preventing and managing cognitive impairments in adults with cancer.

scholarly journals Published randomized controlled trials of surveillance in cancer patients - a systematic review

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Victoria Giglio ◽  
Patricia Schneider ◽  
Kim Madden ◽  
Bill Lin ◽  
Iqbal Multani ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Cancer Patients ◽  
Primary Outcome ◽  
Risk Of Bias ◽  
Cancer Surveillance ◽  
Quality Data ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled

With solid tumor cancer survivorship increasing, the number of patients requiring post-treatment surveillance also continues to increase. This highlights the need for evidence-based cancer surveillance guidelines. Ideally, these guidelines would be based on combined high-quality data from randomized controlled trials (RCTs). We present a systematic review of published cancer surveillance RCTs in which we sought to determine the feasibility of data pooling for guideline development. We carried out a systematic search of medical databases for RCTs in which adult patients with solid tumors that had undergone surgical resection with curative intent and had no metastatic disease at presentation, were randomized to different surveillance regimens that assessed effectiveness on overall survival (OS). We extracted study characteristics and primary and secondary outcomes, and assessed risk of bias and validity of evidence with standardized checklist tools. Our search yielded 32,216 articles for review and 18 distinct RCTs were included in the systematic review. The 18 trials resulted in 23 comparisons of surveillance regimens. There was a highlevel of variation between RCTs, including the study populations evaluated, interventions assessed and follow-up periods for the primary outcome. Most studies evaluated colorectal cancer patients (11/18, [61%]). The risk of bias and validity of evidence were variable and inconsistent across studies. This review demonstrated that there is tremendous heterogeneity among RCTs that evaluate effectiveness of different postoperative surveillance regimens in cancer patients, rendering the consolidation of data to inform high-quality cancer surveillance guidelines unfeasible. Future RCTs in the field should focus on consistent methodology and primary outcome definition.

Comparing active immunotherapy efficacy of PD-L1 ≥ 50% NSCLC patients: A systematic review and meta-analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21139-e21139
Author(s):  
Yi Hu ◽  
Xiaochen Zhao ◽  
Yuezong Bai ◽  
Longgang Cui ◽  
Fan Zhang
Keyword(s):  
Systematic Review ◽  
Overall Survival ◽  
Randomized Controlled Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Difference ◽  
Nsclc Patients

e21139 Background: Several therapies based on immune checkpoint inhibitors (ICIs) have been approved as the 1L standard of care for PD-L1≥ 50% advanced non-small cell lung cancer (NSCLC). However, little is known about the difference in efficacy between different strategies. We conducted a systematic review and meta-analysis to help clinicians choose more reasonable treatment options. Methods: We searched PubMed, Cochrane library, Embase and major conference proceedings from January 2010 to December 2020 for randomized controlled trials that had available subgroup hazard ratios (HRs) for overall survival according to PD-L1≥ 50%. Only drugs met primary outcome or approved by FDA were included for analysis. The primary outcome was the difference in overall survival (OS). HRs and 95% CI were calculated for the pooled OS using a random-effects model. p<0.05 was considered as statistical difference. Results: A total of 10 randomized controlled trials were included for this meta-analysis. The pooled HR and 95% CI for monotherapy, ICI plus chemotherapy and ICI plus ICI were 0.64 (0.55, 0.74), 0.64 (0.51, 0.79) and 0.70 (0.55, 0.90), respectively. There was no statistical differences between ICI monotherapy and ICI plus chemotherapy (HR 1.00, 95% CI 0.77- 1.30), between ICI monotherapy and ICI plus ICI (HR 0.91, 95% CI 0.69- 1.22) or between ICI plus chemotherapy and ICI plus ICI (HR 0.91, 95% CI 0.66- 1.27). Conclusions: For PD-L1≥ 50% NSCLC patients, active ICI monotherapies showed no different efficacy when compared with ICI combination therapies.

P469Minimally interrupted versus uninterrupted non-vitamin K anticoagulants for atrial fibrillation ablation. a meta-analysis of randomized controlled trials

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
B Enache ◽  
H Del Castillo-Carnevali ◽  
O Lairez ◽  
M Postula
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Atrial Fibrillation Ablation ◽  
Controlled Trials ◽  
Minor Bleeding ◽  
Af Ablation ◽  
Randomized Controlled

Abstract Introduction More and more patients undergoing atrial fibrillation (AF) ablation are anticoagulated with direct oral anticoagulants (DOAC). In order to balance the peri-procedural risk of bleeding with the risk of stroke, an important clinical question is whether to continue an interrupted DOAC administration or minimal interrupt by skipping the last one or two doses before the procedure. Dealing with rare events, the randomized controlled trials (RCTs) looking at this question have not been sufficiently powered to give a definitive answer.  Purpose To do a systematic review of the literature comparing an uninterrupted DOAC strategy to minimally interrupted (1-2 doses) strategy in the setting of AF ablation in terms of peri-procedural stroke and bleeding. Methods PubMed, EMBASE, and Cochrane databases were searched for RCTs comparing a strategy of uninterrupted versus minimally interrupted DOAC administration for atrial fibrillation ablation. The primary endpoint was a composite of clinically significant adverse events: ischemic stroke, transient ischemic attack (TIA), systemic embolism, and major or minor bleeding events. A random-effects meta-analysis was performed on the resulting trials. The systematic review protocol was pre-registered in the PROSPERO database. The study selection process followed the PRISMA statement. Results After checking and removing duplicates, 188 articles were screened by reading the title and abstract. 8 of them were selected for a full text screening.  Because 3 were not randomized, finally, 5 RCTs met the inclusion criteria. A total of 1 769 patients were included in the meta-analysis, and the sample size of the individual RCTs ranged from 97 to 846 patients. The overall prevalence of paroxysmal AF varied from 54% to 100%. The mean age of patients ranged from 63,5 to 70 years, and 21,6% to 32,8% of the trial populations were women. Comorbidities, such as hypertension, dyslipidemia, and diabetes, were common. Most patients had CHA2DS2-VASc &lt; 3; range from 1,7 to 2,7We found consistently low rates of strokes, TIAs, systemic embolisms and bleedings across all trials and both arms (RR = 0.98, 95% CI 0.69 – 1.38, I-squared = 0%, p = 0.874).  Conclusion We found no evidence in favor of a difference between uninterrupted and interrupted administration of NOACs regarding the primary outcome of clinical thromboembolic and bleeding. Abstract Figure. Meta-analysis of the primary outcome

Efficacy and Safety of Ginger regarding Human Milk Volume and Related Clinical Outcomes: A Systematic Review of Randomized Controlled Trials

2021 ◽  
pp. 1-7
Author(s):  
Witoo Dilokthornsakul ◽  
Atcharapan Rinta ◽  
Teerapon Dhippayom ◽  
Piyameth Dilokthornsakul
Keyword(s):  
Systematic Review ◽  
Human Milk ◽  
Randomized Controlled Trials ◽  
Primary Outcome ◽  
Healthcare Providers ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Milk Volume ◽  
Single Intervention

<b><i>Background:</i></b> Ginger has been used as a galactagogue in Southeast Asian countries. However, limited evidence of its effect has been reported. This systematic review summarizes the efficacy and safety of ginger regarding human milk volume. <b><i>Methods:</i></b> A systematic review was conducted. Randomized controlled trials (RCTs) which studied the effect of ginger on human milk volume were included. The primary outcome was 24-h human milk volume. <b><i>Results:</i></b> We found five RCTs. Two studies reported ginger as a single intervention, while three studies reported ginger in a combination with other herbs. We found that ginger could enhance human milk volume in mothers with vaginal births. It failed to improve human milk volume in mothers with cesarian section (C-section). Ginger in several combination products has been shown to be effective in enhancing human milk volume, including ginger with pandan, with turmeric and fenugreek, and with Xiong-gui-tiao-xue-yin. No adverse effect directly related to ginger was reported. <b><i>Discussion:</i></b> Ginger could be used to enhance human milk volume in mothers with vaginal births, but not in mothers with C-section. Combined ginger products could also be considered to improve human milk volume. These findings could guide healthcare providers or mothers to consider using ginger to increase human milk production.

scholarly journals Efficacy and Safety of Adalimumab in Noninfectious Uveitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 12 ◽  
Author(s):  
Biao Li ◽  
Haoran Li ◽  
Li Zhang ◽  
Yanlin Zheng
Keyword(s):  
Systematic Review ◽  
Treatment Failure ◽  
Randomized Controlled Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Mean Difference ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Risk Of Treatment

Background: Patients with noninfectious uveitis (NIU) are at risk of systemic side effects of long-term glucocorticoid therapy and uncontrolled inflammatory complications. In urgent need to identify more aggressive therapies, adalimumab (ADA) may be the right choice.Objectives: To summarize the current evidence from randomized controlled trials (RCTs) regarding the efficacy and safety of ADA in the treatment of NIU.Methods: We searched Pubmed, Embase, Web of Science, Cochrane Library databases, and Clinical Trials Registry for qualifying articles from their inception to November 19, 2020, with no language restriction. Randomized controlled trials comparing ADA with conventional routine treatment in noninfectious uveitis patients of any age, gender, or ethnicity were included. The primary outcome was the time to treatment failure (TF). The secondary outcomes were the change in best-corrected visual acuity (BCVA), change in the anterior chamber (AC) cell grade, change in vitreous haze (VH) grade, and adverse events (AEs).Main results: The six studies comprised 605 participants in all, and the sample size of each study ranged from 16 to 225. The overall pooled results of the primary outcome (HR = 0.51; 95% CI, 0.41 to –0.63) showed that ADA nearly halved the risk of treatment failure compared to placebo for NIU patients. The pooled mean difference of change in BCVA was -0.05 (95% CI, −0.07 to −0.02). The pooled mean difference of change in AC cell grade and VH grade was −0.29 (95% CI, −0.62 to −0.05) and −0.21 (95% CI, −0.32 to −0.11), respectively. The incidence of AEs in the ADA group was numerically higher than that of AEs in the placebo group (2,237 events and 9.40 events per patient-year, equivalent to 1,257 events and 7.79 events per patient-year).Conclusion: This meta-analysis of six RCTs further confirmed that ADA considerably lowered the risk of treatment failure or visual loss, and moderately reduced AC cell grades and VH grades with slightly more AEs, as compared to placebo. ADA is both effective and safe in treating NIU.Systematic Review Registration: [https://clinicaltrials.gov], identifier [CRD42020217909].

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