scholarly journals Relative Risk Estimation in Randomized Controlled Trials: A Comparison of Methods for Independent Observations

2011 ◽  
Vol 7 (1) ◽  
pp. 1-31 ◽  
Author(s):  
Lisa N Yelland ◽  
Amy B Salter ◽  
Philip Ryan
Keyword(s):  
Relative Risk ◽  
Randomized Controlled Trials ◽  
Risk Estimation ◽  
Controlled Trials ◽  
Comparison Of Methods ◽  
Randomized Controlled ◽  
Independent Observations

scholarly journals Lower Risk of Recurrence After Mesh Repair Versus Non-Mesh Sutured Repair in Open Umbilical Hernia Repair: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2018 ◽  
Vol 108 (3) ◽  
pp. 187-193 ◽  
Author(s):  
T. Bisgaard ◽  
R. Kaufmann ◽  
M. W. Christoffersen ◽  
P. Strandfelt ◽  
L. L. Gluud
Keyword(s):  
Relative Risk ◽  
Confidence Interval ◽  
Randomized Controlled Trials ◽  
Mesh Repair ◽  
Umbilical Hernia ◽  
Meta Analysis ◽  
Seroma Formation ◽  
Controlled Trials ◽  
Randomized Controlled

Background and Aims: The use of mesh repair in a small- or middle-sized umbilical hernia remains controversial, and evidence is based on only few and small heterogeneous randomized trials. The primary aim was to assess differences, if any, in recurrence (clinical and reoperation), and secondary aim was to assess differences in infections, seroma formation, hematomas, chronic pain, cosmetic result, and quality of life. Method: A systematic review (predefined search strategy) and meta-analyses were conducted based on pre-study strict and well-defined methodology. The literature search was completed on 1 January 2018. The study protocol was registered in PROSPERO. Results: Five randomized controlled trials were identified (mesh repair, n = 326 versus non-mesh sutured repair, n = 330) and 602 records were excluded. Randomized controlled trials included patients with defect diameters of ⩾1 to 4 cm. Mesh repair reduced the risk of recurrence compared with sutured repair with a relative risk of 0.28 (95% confidence interval = 0.13–0.58, I2 = 0%, number needed to treat = 13 patients). Additional analyses found no differences between the two surgical techniques regarding infection (relative risk = 0.80, 95% confidence interval = 0.36–1.79), seroma formation (relative risk = 1.38, 95% confidence interval = 0.57–3.32), or hematomas (relative risk = 0.55, 95% confidence interval = 0.23–1.30). Lack of sufficient data precluded meta-analysis evaluating risk of seroma formation, hematomas, chronic pain, cosmetic result, and quality of life. Conclusion: Mesh repair is recommended for umbilical hernia of ⩾1 to 4 cm. More evidence is needed for the optimal placement of the mesh (sublay or onlay) and the role of mesh in patients with an umbilical hernia <1 cm.

scholarly journals Safety of Intravenous Iron in Dialysis

2018 ◽  
Vol 13 (3) ◽  
pp. 457-467 ◽  
Author(s):  
Ingrid Hougen ◽  
David Collister ◽  
Mathieu Bourrier ◽  
Thomas Ferguson ◽  
Laura Hochheim ◽  
...  
Keyword(s):  
Relative Risk ◽  
Confidence Interval ◽  
Randomized Controlled Trials ◽  
Cardiovascular Events ◽  
Observational Studies ◽  
Intravenous Iron ◽  
Hazard Ratio ◽  
Controlled Trials ◽  
Randomized Controlled

Background and objectivesThe safety of intravenous iron dosing in dialysis is uncertain. Higher-dose intravenous iron may be associated with a higher risk of infections, cardiovascular events, hospitalizations, and mortality. This systematic review aimed to determine the safety of higher-dose versus lower-dose intravenous iron, oral iron, or no iron supplementation in adult patients treated with dialysis.Design, setting, participants, & measurementsWe searched Medline, EMBASE, Cochrane library, and CINAHL from inception to January 6, 2017 for randomized, controlled trials and observational studies comparing higher-dose intravenous iron with lower-dose intravenous iron, oral iron, or no iron in patients treated with dialysis that had all-cause mortality, infection, cardiovascular events, or hospitalizations as outcomes.ResultsOf the 2231 eligible studies, seven randomized, controlled trials and 15 observational studies met inclusion criteria. The randomized, controlled trials showed no association between higher-dose intravenous iron (>400 mg/mo for most studies) and mortality (six studies; n=970; pooled relative risk, 0.93; 95% confidence interval, 0.47 to 1.84; follow-up ranging from 35 days to 26 months) or infection (four studies; n=743; relative risk, 1.02; 95% confidence interval, 0.74 to 1.41). The observational studies showed no association between higher-dose intravenous iron (>200 mg/mo for most studies) and mortality (eight studies; n=241,408; hazard ratio, 1.09; 95% confidence interval, 0.98 to 1.21; follow-up ranging from 3 to 24 months), infection (eight studies; n=135,532; pooled hazard ratio, 1.13; 95% confidence interval, 0.99 to 1.28), cardiovascular events (seven studies; n=135,675; hazard ratio, 1.18; 95% confidence interval, 0.90 to 1.56), or hospitalizations (five studies; n=134,324; hazard ratio, 1.08; 95% confidence interval, 0.97 to 1.19).ConclusionsHigher-dose intravenous iron does not seem to be associated with higher risk of mortality, infection, cardiovascular events, or hospitalizations in adult patients on dialysis. Strength of this finding is limited by small numbers of participants and events in the randomized, controlled trials and statistical heterogeneity in observational studies.

Mindfulness training for smoking cessation: A meta-analysis of randomized-controlled trials

2016 ◽  
Vol 22 (14) ◽  
pp. 1841-1850 ◽  
Author(s):  
Maria Theodora Oikonomou ◽  
Marios Arvanitis ◽  
Robert L Sokolove
Keyword(s):  
Systematic Review ◽  
Smoking Cessation ◽  
Relative Risk ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Mindfulness Training ◽  
Controlled Trials ◽  
Percent Confidence Interval ◽  
Review Of The Literature ◽  
Randomized Controlled

Recent studies have shown that mindfulness training has a promising potential for smoking treatment. In order to examine the efficacy of mindfulness training in smoking cessation, we performed a systematic review of the literature and meta-analysis of randomized controlled trials. Four randomized controlled trials with 474 patients were included in our analysis. The results showed that 25.2 percent of participants remained abstinent for more than 4 months in the mindfulness group compared to 13.6 percent of those who received usual care therapy (relative risk, 1.88; 95 percent confidence interval, 1.04–3.40). Our results suggest that mindfulness training may have an important role to play in efforts to lower cigarette smoking rates.

Relative risk of pneumonitis or interstitial lung disease (ILD) associated with the use of cyclin-dependent kinase inhibitors (CDK4/6i): A systematic review and meta-analysis of phase 3 randomized controlled trials.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1072-1072
Author(s):  
Nusrat Jahan ◽  
Sariya Wongsaengsak ◽  
Shabnam Rehman ◽  
Myrian Vinan-Vega ◽  
Lukman Aderoju Tijani ◽  
...  
Keyword(s):  
Systematic Review ◽  
Relative Risk ◽  
Interstitial Lung Disease ◽  
Lung Disease ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cyclin Dependent Kinase ◽  
Phase 3 ◽  
Randomized Controlled

1072 Background: All three currently approved cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) such as palbociclib, abemaciclib, and ribociclib are reported to cause significant pulmonary toxicities including fatal pneumonitis or interstitial lung disease (ILD). We conducted a systematic review and meta-analysis of phase 3 randomized controlled trials (RCTs) to determine the relative risk of pneumonitis or ILD associated with CDK4/6i. Methods: We conducted a systematic search using PRISMA guidelines in PubMed, EMBASE, American Society of Clinical Oncology and San Antonio Breast Cancer Symposium meeting abstracts from inception through Jan 30, 2021. Phase 3 RCTs using CDK4/6i in the intervention arm and reporting the number of events for pneumonitis or ILD were included in the analysis. The Cochran-Mantel-Haenszel method and random effects model were used to calculate the pooled risk ratio (RR) with 95% confidence interval (CI). Heterogeneity was tested by Cochran’s Q test and I2 value. Results: Five phase 3 RCTs — MONALEESA-3, MONALEESA-7, MONARCH plus, monarchE, and PALLAS — reported the number of events for any grade pneumonitis or ILD and were included in the final analysis. A total of 13,191 patients — 6,758 in the CDK4/6i arm and 6,433 in the control arm — were analyzed. Following regimens were used in CDK4/6i arms — MONALEESA-3: ribociclib + fulvestrant; MONALEESA-7: ribociclib + tamoxifen or a non-steroidal aromatase inhibitor + goserelin; MONARCH plus: in cohort A, abemaciclib + anastrozole or letrozole, and in cohort B, abemaciclib + fulvestrant; MonarchE: abemaciclib + standard-of-care adjuvant endocrine therapy (ET); PALLAS: Palbociclib + ET. In the control arms, all studies used placebo and respective endocrine therapies. Any grade pneumonitis or ILD was reported in 1.64% of patients in the CDK4/6i arm versus 0.68% of patients in the control arm. The pooled RR of any grade pneumonitis or ILD was 2.26, 95% CI: 1.60-3.19, P < 0.00001, I2 = 0%. Grade 3/4 pneumonitis or ILD was reported in 0.28% of patients in the CDK4/6i arm and 0.06% of patients in the control arm with pooled RR of 2.35, 95% CI: 0.37-15.08, P = 0.37, I2 = 34%. One grade 5 pneumonitis was reported in the monarchE. Conclusions: Cyclin-dependent kinase 4/6 inhibitors are associated with increased risk of any grade pneumonitis or ILD. Early detection and prompt initiation of appropriate interventions are vital to reduce the morbidity and mortality associated with CDK4/6i induced pneumonitis or ILD.

scholarly journals Intrawound Treatment for Prevention of Surgical Site Infections in Instrumented Spinal Surgery: A Systematic Comparative Effectiveness Review and Meta-Analysis

2018 ◽  
Vol 9 (2) ◽  
pp. 219-230 ◽  
Author(s):  
Justin V. C. Lemans ◽  
Sebastiaan P. J. Wijdicks ◽  
Willemijn Boot ◽  
Geertje A. M. Govaert ◽  
R. Marijn Houwert ◽  
...  
Keyword(s):  
Relative Risk ◽  
Randomized Controlled Trials ◽  
Spine Surgery ◽  
Spinal Surgery ◽  
Meta Analysis ◽  
Surgical Site Infections ◽  
Controlled Trials ◽  
Local Antibiotics ◽  
Randomized Controlled ◽  
Instrumented Spine Surgery

Study Design: Systematic review and meta-analysis. Objectives: To determine the efficacy of intrawound treatments in reducing deep surgical site infections (SSIs) in instrumented spinal surgery. Methods: The electronic databases MEDLINE, EMBASE, and Cochrane were systematically searched for intrawound treatments for the prevention of SSIs in clean instrumented spine surgery. Both randomized controlled trials and comparative cohort studies were included. The results of included studies were pooled for meta-analysis. Results: After full text- and reference screening, 20 articles were included. There were 2 randomized controlled trials and 18 observational studies. Sixteen studies investigated the use of intrawound antibiotics, and 4 studies investigated the use of intrawound antiseptics. The relative risk of deep SSI for any treatment was 0.26 (95% confidence interval [CI] 0.16-0.44, P < .0001), a significant reduction compared with controls receiving no treatment. For patients treated with local antibiotics the relative risk was 0.29 (95% CI 0.17-0.51, P < .0001), and patients treated with local antiseptics had a relative risk of 0.14 (95% CI 0.05-0.44, P = .0006). Conclusions: Both the use of antibiotic and antiseptic intrawound prophylactics was associated with a significant 3 to 7 times reduction of deep SSIs in instrumented spine surgery. No adverse events were reported in the included studies.

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