Application of random effect ordinal regression model for outcome evaluation of two randomized controlled trials

2001 ◽  
Vol 20 (24) ◽  
pp. 3769-3776 ◽  
Author(s):  
Chiara Marinacci ◽  
Patrizia Schifano ◽  
Piero Borgia ◽  
Carlo A. Perucci
Keyword(s):  
Regression Model ◽  
Randomized Controlled Trials ◽  
Random Effect ◽  
Ordinal Regression ◽  
Outcome Evaluation ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Ordinal Regression Model

scholarly journals Effect of janus kinase inhibitors and methotrexate combination on malignancy in patients with rheumatoid arthritis: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Vinod Solipuram ◽  
Akhila Mohan ◽  
Roshniben Patel ◽  
Ruoning Ni
Keyword(s):  
Rheumatoid Arthritis ◽  
Combination Therapy ◽  
Randomized Controlled Trials ◽  
Random Effect ◽  
Janus Kinase ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Significant Difference ◽  
Risk Of Malignancy

Abstract Background Rheumatoid arthritis (RA) is a systemic autoimmune disease. The combination therapy of methotrexate (MTX) and Janus kinase inhibitor (JAKi) is commonly used. Patients with RA are at increased risk of malignancy, however, it remains unclear whether the combination therapy is associated with a higher risk. Objective To assess the malignancy risk among patients with RA receiving combination therapy of JAKi and MTX compared to MTX alone. Methods PubMed, Cochrane and Embase were thoroughly searched for randomized controlled trials (RCTs) in patients with RA receiving JAKi and MTX, from inception to July 2020. Primary endpoints were malignancy events, Non melanomatous skin cancer (NMSC) and malignancy excluding NMSC and secondary endpoints were serious adverse events (SAE), deaths. Risk ratio (RR) and 95% CI were calculated using the Mantel–Haenszel random-effect method. Results 659 publications were screened and 13 RCTs with a total of 6911 patients were included in the analysis. There was no statistically significant difference in malignancy [RR = 1.42; 95% CI (0.59, 3.41)], neither NMSC [RR = 1.44 (0.36, 5.76)] nor malignancies excluding NMSC [RR = 1.12 (0.40, 3.13)]. No statistically significant difference between the two groups for SAE [RR = 1.15 (0.90, 1.47)] and deaths [RR = 1.99 (0.75, 5.27)] was found. Conclusion The adjunction of JAKi to MTX is not associated with an increased risk of malignancy when compared to MTX alone. There is no increased risk of SAE and deaths when compared to MTX alone in patients with RA.

scholarly journals Multivessel versus culprit-only PCI in STEMI patients with multivessel disease: meta-analysis of randomized controlled trials

2020 ◽  
Vol 109 (11) ◽  
pp. 1381-1391 ◽  
Author(s):  
Hans-Josef Feistritzer ◽  
Alexander Jobs ◽  
Suzanne de Waha-Thiele ◽  
Ingo Eitel ◽  
Anne Freund ◽  
...  
Keyword(s):  
Cardiogenic Shock ◽  
Randomized Controlled Trials ◽  
Primary Endpoint ◽  
Meta Analysis ◽  
Random Effect ◽  
Final Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Risk Of Death ◽  
Randomized Controlled

Abstract Aims To perform a pairwise meta-analysis of randomized controlled trials (RCTs) comparing multivessel percutaneous coronary intervention (PCI) and culprit vessel-only PCI in ST-elevation myocardial infarction (STEMI) patients without cardiogenic shock. Methods We searched MEDLINE, Cochrane Central Register of Controlled Trials, and Embase for RCTs comparing multivessel PCI with culprit vessel-only PCI in STEMI patients without cardiogenic shock and multivessel coronary artery disease. Only RCTs reporting mortality or myocardial reinfarction after at least 6 months following randomization were included. Hazard ratios (HRs) were pooled using random-effect models. Results Nine RCTs were included in the final analysis. In total, 523 (8.3%) of 6314 patients suffered the combined primary endpoint of death or non-fatal reinfarction. This primary endpoint was significantly reduced with multivessel PCI compared to culprit vessel-only PCI (HR 0.63, 95% confidence interval [CI] 0.43–0.93; p = 0.03). This finding was driven by a reduction of non-fatal reinfarction (HR 0.64, 95% CI 0.52–0.79; p = 0.001), whereas no significant reduction of all-cause death (HR 0.77, 95% CI 0.44–1.35; p = 0.28) or cardiovascular death (HR 0.64, 95% CI 0.37–1.11; p = 0.09) was observed. Conclusions In STEMI patients without cardiogenic shock multivessel PCI reduced the risk of death or non-fatal reinfarction compared to culprit vessel-only PCI.

scholarly journals A Systematic Review and Meta-Analysis of Randomized Controlled Trials Comparing the Safety of Dapagliflozin in Type 1 Diabetes Patients

2020 ◽  
Author(s):  
Sumanta Saha ◽  
Sujata Saha
Keyword(s):  
Systematic Review ◽  
Type 1 Diabetes ◽  
Side Effects ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Random Effect ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomized Controlled

Background and Purpose: The dapagliflozin’s safety profile in insulin-treated adult type-1 diabetes mellites (T1DM) patients remains poorly explored. Therefore, this systematic review and meta-analysis compared the risk of all-cause side effects, study discontinuation of participants due to side effects, urinary tract infection (UTI), diabetic ketoacidosis, and hypoglycemia between dapagliflozin 10 mg and dapagliflozin 5 mg, dapagliflozin 10 mg and placebo, and dapagliflozin 5 mg and placebo.Materials and Methods: Parallel-arm randomized controlled trials juxtaposing the above outcomes between the afore-mentioned interventions were eligible for inclusion in this study and were searched in PubMed, Embase, and Scopus. Utilizing the Cochrane tool, the risk of bias was assessed in the recruited trials. Finally, by random-effect meta-analysis, each outcome was compared among the above interventions, and the risk ratio was estimated.Results: Four trials of varying length (1-52 weeks) sourcing data from almost 1760 participants from about 32 nations were reviewed. Overall, the trials had a low or unclear risk of bias, and only one was at a high risk of bias.  Compared to the placebo, the risk of side effects was higher in those treated with dapagliflozin 5 mg (RR=1.10; 95% CI=1.02-1.18; p=0.014; I2=0%). UTI risk was less with the 10mg dapagliflozin than its lower dose (RR=0.50; 95% CI=0.32-0.79; p-value=0.003; I2=0%). All the remaining comparisons were statistically not significantly different between the juxtaposed intervention pairs.Conclusion: In contrast to placebo, dapagliflozin 5mg increased the risk of overall adversities in insulin-treated type-1 diabetes, and dapagliflozin 10 mg had a reduced risk of UTI than its 5mg preparation.

scholarly journals Benefits of balneotherapy in the management of fibromyalgia syndrome: a systematic review and meta-analysis of randomized controlled trials

2020 ◽  
Author(s):  
Chun-Feng Cao ◽  
Kun-Long Ma ◽  
Qian-Lu Li ◽  
Fu-Jun Luan ◽  
Qun-Bo Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Fibromyalgia Syndrome ◽  
Meta Analysis ◽  
Random Effect ◽  
Fibromyalgia Impact Questionnaire ◽  
Long Term Results ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Searching Strategy

Abstract Objective To assess the effectiveness of balneotherapy (BT) in the management of fibromyalgia syndrome (FMS). Methods The Cochrane Library, EMBASE, MEDLINE, and PubMed were thoroughly searched for relevant studies with a pre-specified searching strategy (from their inception to May 31 st , 2019), to identify randomized controlled trials (RCTs) evaluating BT in FMS management. The primary outcomes were pain, Fibromyalgia Impact Questionnaire (FIQ), Tender Points Count (TPC), Beck’s Depression Index (BDI). A meta-analysis was performed to identify risk ration (RR) or standardized mean difference (SMD) where appropriate, 95%CI with random-effect and consistent models. Results Ten RCT studies with 611 participants were included. Pooled results showed that BT can benefit FMS with significant improvement reflected as, pain (SMD= -0.90, 95%CI [−1.37 to −0.42] I 2 =86%), FIQ (SMD= −0.81, 95% CI [−1.24 to −0.38] I 2 =84%), TPC (SMD= −0.88, 95% CI [−1.63 to −0.14] I 2 =91%) and BDI (SMD= −0.29, 95% CI [−0.53 to −0.05] I 2 =22%) at the end of treatment. However, there was no significant effect on BDI (SMD= −0.57, 95% CI [−1.40 to 0.26]) at follow up. Conclusion Based on 12 to 48 weeks observation, pooled evidence from RCTs indicates BT may reduce pain and improve the quality of life of patients with FMS. Definitive, large-sample studies are needed, with focus on long-term results and maintenance of the beneficial effects.

Human Milk Expression After Domperidone Treatment in Postpartum Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2018 ◽  
Vol 35 (3) ◽  
pp. 501-509 ◽  
Author(s):  
Alicia Taylor ◽  
Gabrielle Logan ◽  
Laurie Twells ◽  
Leigh Anne Newhook
Keyword(s):  
Human Milk ◽  
Randomized Controlled Trials ◽  
Milk Production ◽  
Meta Analysis ◽  
Random Effect ◽  
The United States ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Milk Volume ◽  
Insufficient Milk

Background: Insufficient milk production is among the most cited reasons by mothers for discontinuing breastfeeding. Medications that can increase milk production, such as domperidone, an off-label galactagogue, are often prescribed. Domperidone is controversial as it is not approved for any purpose in the United States and is approved only for gastrokinetic purposes in Canada and other countries. Research aim: The aim was to update the existing literature on the efficacy of domperidone as a galactagogue compared to placebo when given to mothers with insufficient human milk production. The primary outcome is the change in expressed human milk volume per day from baseline. Methods: The authors independently searched the literature from inception to May 2018. The search included any randomized controlled trials examining the efficacy of domperidone increasing mothers’ expressed human milk, measured via a human milk pump. Both authors independently assessed quality and risk of bias and extracted relevant data. Meta-analysis on expressed human milk volume per day was performed. Results: Seven studies met the inclusion criteria for review; two were excluded from the meta-analysis due to quality grading and insufficient reporting of the outcome of interest. Five studies ( N = 239) were combined in the meta-analysis. The effect size showed an increase in the mean difference of expressed human milk volume in mothers given domperidone, 93.97 mL per day (95% CI [71.12, 116.83 mL]; random effect, T2 0.00, I2 0%). Conclusion: This meta-analysis reports a significant improvement in expressed human milk volume per day with the use of domperidone in mothers experiencing insufficient human milk production.

Multivessel versus culprit-only PCI in STEMI patients with multivessel disease: meta-analysis of randomized controlled trials

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Feistritzer ◽  
A Jobs ◽  
S De Waha-Thiele ◽  
I Eitel ◽  
A Freund ◽  
...  
Keyword(s):  
Cardiogenic Shock ◽  
Randomized Controlled Trials ◽  
Primary Endpoint ◽  
Meta Analysis ◽  
Random Effect ◽  
Multivessel Disease ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Risk Of Death ◽  
Randomized Controlled

Abstract Background Previous randomized controlled trials (RCTs) indicated a benefit of multivessel percutaneous coronary intervention (PCI) compared to culprit vessel-only PCI in ST-elevation myocardial infarction (STEMI) without cardiogenic shock. Purpose To perform a pairwise meta-analysis of RCTs, already including the recently published COMPLETE (The Complete versus Culprit-Only Revascularization Strategies to Treat Multivessel Disease after Early PCI for STEMI) trial, comparing multivessel PCI and culprit vessel-only PCI in STEMI patients without cardiogenic shock. Methods We searched MEDLINE, Cochrane Central Register of Controlled Trials, and Embase for randomized controlled trials (RCTs) comparing multivessel PCI with culprit vessel-only PCI in STEMI patients without cardiogenic shock and multivessel coronary artery disease. Only RCTs reporting mortality or myocardial reinfarction after at least 6 months following randomization were included. Hazard ratios (HRs) were pooled using random-effect models. Results Nine RCTs were included in the final analysis. In total, 523 (8.3%) of 6,314 patients suffered the combined primary endpoint of death or non-fatal reinfarction. This primary endpoint was significantly reduced with multivessel PCI compared to culprit vessel-only PCI (HR 0.63, 95% confidence interval [CI] 0.43–0.93; p=0.03). This finding was driven by a reduction of non-fatal reinfarction (HR 0.64, 95% CI 0.52–0.79; p=0.001), whereas no significant reduction of all-cause death (HR 0.77, 95% CI 0.44–1.35; p=0.28) or cardiovascular death (HR 0.64, 95% CI 0.37–1.11; p=0.09) was observed. Conclusion In STEMI patients without cardiogenic shock multivessel PCI reduced the risk of death or non-fatal reinfarction compared to culprit vessel-only PCI. Funding Acknowledgement Type of funding source: None

Effects of melatonin supplementation on oxidative stress: a systematic review and meta-analysis of randomized controlled trials

2020 ◽  
Vol 41 (4) ◽  
Author(s):  
Parivash Ghorbaninejad ◽  
Fatemeh Sheikhhossein ◽  
Farhang Djafari ◽  
Aliyu Jibril Tijani ◽  
Saba Mohammadpour ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Random Effect ◽  
Random Effect Model ◽  
Protein Carbonyl ◽  
Considerable Effect ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Total Antioxidant

AbstractObjectivesPrevious studies showed that melatonin supplementation may suppress oxidative stress, however, the results have not been consistent. So, we conducted this meta-analysis to assess the precise relationship between melatonin supplementation and oxidative stress.MethodsPubMed and Scopus were searched for randomized controlled trials that investigated the effect of melatonin supplementation on oxidative stress up to March 2020. Heterogeneity was assessed by Cochran’s Q test and I-square (I2) statistic. Data were pooled using the random effect model and standardized mean difference (SMD) was considered as the summary effect size. Also, standard methods were used for assessment of sensitivity analysis and publication bias.ResultsWe included 15 related articles and our findings indicated that melatonin supplementation significantly increased total antioxidant capacity (TAC) level (SMD: 1.03, 95% CI: 0.24, 1.81, p=0.011) and reduced protein carbonyl (PCO) (SMD: −1.78, 95% CI: −2.97, −0.58, p=0.004) and malondialdehyde (MDA) levels (SMD: −0.94, 95% CI: −1.48, −0.40, p=0.001). Additionally, there was considerable effect on TAC level by using ≥20 mg/d melatonin and in people under 35 years old. MDA level also decreased using dosage of below 20 mg/d and in people ≥35 years old.ConclusionsThe present study showed a promising effect of melatonin administration for reducing MDA, PCO, and increasing TAC levels. However, further studies especially with more attention to PCO level assessment are needed to confirm the findings of the present study in larger samples on different populations.

scholarly journals Different Dosage Regimens of Eptinezumab for the Treatment of Migraine: A Meta-Analysis from Randomized Controlled Trials

2020 ◽  
Author(s):  
Zeya Yan ◽  
Tao Xue ◽  
Shujun Chen ◽  
Xin Wu ◽  
Xingyu Yang ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Neurological Diseases ◽  
Meta Analysis ◽  
Random Effect ◽  
Random Effect Model ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Standard Mean Difference ◽  
Significant Efficacy

Abstract BackgroundMigraine is one of the most common neurological diseases around the world and calcitonin gene-related peptide（CGRP）plays an important role in its pathophysiology. Therefore, in the present study, we evaluated the efficacy of monoclonal antibodies blocking the CGRP ligand or receptor in episodic and chronic migraine. ObjectiveThe objective of our study is implementing a meta-analysis to systematically evaluate the efficacy and safety of eptinezumab for the treatment of migraine compared with placebo.MethodWe searched the Medline, Embase, Cochrane Library and Clinicaltrials.gov for randomized controlled trials (RCTs) which were performed to evaluate eptinezumab versus placebo for migraine up to September 2020. The data was assessed by Review Manager 5.3 software. The risk ratio (RR) and standard mean difference (SMD) were analyzed using dichotomous outcomes and continuous outcomes respectively with a random effect model.ResultWe collected 2,739 patients from 4 RCTs: the primary endpoint of efficacy was the change from baseline to week 12 in mean monthly migraine days (MMDs). We found that eptinezumab (30mg，100mg，300mg) led to a significant reduction in MMDs (P=0.0001,P < 0.00001, P < 0.00001) during 12 weeks compared with placebo, especially with 300mg. For the safety, we compared and concluded the treatment emergent adverse events (TEAEs) of the 4 RCTs. This indicated no evident statistical difference between eptinezumab and placebo.ConclusionsIn the present study, we found that eptinezumab is safe and has significant efficacy in the treatment of migraine, especially the dose of 300 mg.

Treatment of metastatic castration sensitive prostate cancer (mCSPC) by disease volume: A systematic review and a meta-analysis.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17539-e17539
Author(s):  
Qurat Ul Ain Riaz Sipra ◽  
Irbaz Bin Riaz ◽  
Noureen Asghar ◽  
Rabbia Siddiqi ◽  
Steven R Hwang ◽  
...  
Keyword(s):  
Overall Survival ◽  
Randomized Controlled Trials ◽  
Treatment Options ◽  
Random Effect ◽  
Random Effect Model ◽  
Progression Free Survival ◽  
High Volume ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Initial Agent

e17539 Background: Chemotherapy with Docetaxel (D) or androgen pathway inhibition (API) with Abiraterone Acetate plus prednisone (AAP), Aplautamide(APA) and Enzalutamide(E) are acceptable, FDA approved treatment options for mCSPC. It is not clear whether the magnitude of benefit varies by the choice of initial agent [chemotherapy vs API] or by volume of disease [High vs Low]. Data is now available from all registration trials by volume status and motivated this analysis to inform initial treatment choice in mCSPC. Methods: We systematically searched MEDLINE(Ovid), Embase, and Scopus for randomized controlled trials of chemotherapy(D) or APIs (AAP, APA, ENZ) that had available hazard ratios (HRs) for overall survival (OS) and Progression Free Survival (PFS) according to patient’s volume of disease. We also reviewed abstracts and presentations from all major conference proceedings. We calculated the pooled overall survival HR and 95% CI by chemotherapy and APIs and by high volume(HVD) and low volume(LVD) using a random effect model, and tested for heterogeneity to assess the null hypothesis that no difference in the survival advantage exists by choice of initial agent and volume of disease. Results: Of 4456 studies identified in our search, there were 8 eligible randomized controlled trials that were included in the analysis. Both D and APIs significantly improved PFS [HR 0.48; 0.45-0.51] and OS [0.72; 0.64-0.81] when added to ADT, however the latter was associated with significantly higher improvement in PFS( P < 0.01) and OS (P = 0.03). In patients treated with D, patients with HVD derive significantly more benefit as compared to LVD( P = 0.046) and patients treated with APIs both HVD and LVD patients derive similar benefit( P = 0.80) (Table). Conclusions: mCSPC patients derive higher magnitude of survival benefit when treated with APIs as compared to D; however, D may be preferred in HVD patients. [Table: see text]

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