scholarly journals An index of the quality of evidence in meta-analysis of randomized controlled trials

2017 ◽  
Author(s):  
Devon D. Brewer

The quality of evidence in meta-analysis of randomized controlled trials is the degree to which the estimated effect represents the "truth." Current approaches to assessing the quality of evidence focus on trial design and methods. I describe a new quality of evidence index composed of four sub-indexes that measure pre-registration, independent replication, data availability, and trial design and methods, respectively. This index is systematic, objective, and quantitative. I illustrate the index with an empirical example and provide a spreadsheet for easy calculation.

2021 ◽  
Author(s):  
Chunxia Huang ◽  
Zunjiang Li ◽  
Yingxin Long ◽  
Dongli Li ◽  
Manhua Huang ◽  
...  

Abstract Background: The sedative effect of intraoperative sedation in elderly surgery exerts critical influence on the prognosis. Comparison on the safety and efficacy between Dexmedetomidine and Midazolam in many clinical randomized controlled trials (RCTs) were inconsistent and suspicious. We aimed to comprehensively evaluate the safety and efficacy between Dexmedetomidine and Midazolam for intraoperative sedation in the elderly via meta-analysis and systematic reviews.Methods: RCTs regarding to the comparison of sedative effects and safety between Dexmedetomidine and Midazolam in elderly patients (aged ≥ 60 years) will be comprehensively searched from 2000.10 to 2021.05 through 4 English databases and 4 Chinese databases. After extraction in duplicate, the systematic review and meta-analysis will be performed on the primary outcomes (hemodynamic changes, sedative effect, cognitive function) and secondary outcomes (analgesic effect, surgical characteristics, complications or adverse reactions) for assessing the two therapy methods using Review manage software (Version 5.3). Sensitivity analysis will be conducted to evaluate the heterogeneity of the results, funnel plot and Egger’s test will be performed to analyze publication bias of the included studies, and test sequential analysis will be applied to assess the robustness and reliability of preliminary meta-analysis results. Finally, rating quality of evidence and strength of recommendations on the meta results will be summarized by rating quality of evidence and strength of recommendations (GRADE) approach. Discussion: This systematic review and meta-analysis will evaluate the safety and efficacy between Dexmedetomidine and Midazolam for intraoperative sedation in the elderly, it will give an insight on the application of Dexmedetomidine and Midazolam, and will provide evidences-based reference for clinical decision makings.Systematic review registration: PROSPERO (CRD42021221897).


2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Wenjing Huang ◽  
Qi Bao ◽  
De Jin ◽  
Fengmei Lian

Objective. We assess the clinical effect of compound Danshen dripping pill (CDDP) for treating diabetic retinopathy (DR). Methods. Electronic databases were searched from January 2001 to October 2016 to locate randomized controlled trials (RCTs). Efficacy was measured as main outcome and microaneurysms, hemorrhage, exudate, vision, and fundus fluorescein angiography (FFA) were measured as second outcomes. Methodological quality for each study was evaluated, RevMan 5 software was used to assess treatment effects, and GRADE was used to rate quality of evidence. Results. We located 13 RCTs and methodological quality was evaluated as high risk. Statistics indicated CDDP for treating DR was better than controls and DR risk was reduced 64% with CDDP (RR: 0.36, P=0.68); retinal microaneurysms (MD = −4.32NO, P<0.00001); retinal hemorrhages (MD = −0.70PD, P=0.03); exudate improvements (MD = −0.09PD, P=0.79); visual changes (MD = −0.12 letter, P=0.006); FFA (RR: 0.40, P=0.003). About GRADE, quality of evidence was “low.” Conclusion. CDDP may be safe and efficacious for treating or delaying DR and may improve vision or delay vision loss.


2021 ◽  
Author(s):  
Rui Cheng ◽  
Xiao-long Ye ◽  
Xu-jun Qin ◽  
Yi Wan ◽  
Meng Xu

Abstract Background: The efficacy of interventions for elderly patients with sarcopenia has received increasing attention. Exercise and nutrition have been recognized as effective treatments for sarcopenia in many studies. However, evidence-based support from relevant studies is still lacking. Methods: The PubMed, Embase, Cochrane Library, VIP, CNKI, and SinoMed databases were searched. The basis for the diagnosis of sarcopenia, general condition of the subjects, duration and methods of exercise/nutritional therapy, outcome indicators, and quality of evidence were evaluated, and a meta-analysis of differences in treatment outcomes between the groups from baseline to the end of each study was conducted. Results: A total of 1860 papers were screened, including six randomized controlled trials, and the effects of protein intervention under exercise conditions on muscle mass, strength, and function in elderly patients with sarcopenia were investigated. The results showed that protein supplementation under resistance exercise conditions had the following effects on elderly patients with sarcopenia: there was a significant difference in knee flexion and extension strength (p = 0.02), grip strength (p = 0.02), fat mass (p = 0.04), and normal pace and pace (p = 0.0008 and p = 0.0010, respectively) between the intervention group and baseline data.Conclusion: The meta-analysis revealed some positive effects of protein intervention treatment under exercise conditions on elderly patients with sarcopenia. However, the quality of evidence is low. High-quality randomized controlled trials should be conducted in the future to provide a better clinical basis. Keywords: Sarcopenia, Exercise, Proteins


2019 ◽  
Vol 48 (4) ◽  
pp. 1000-1013 ◽  
Author(s):  
Alberto Grassi ◽  
Kristian Samuelsson ◽  
Pieter D’Hooghe ◽  
Matteo Romagnoli ◽  
Massimiliano Mosca ◽  
...  

Background: Several devices for obtaining dynamic fixation of the syndesmosis have been introduced in recent years, but their efficacy has been tested in only a few randomized controlled trials (RCTs), without demonstrating any clear benefit over the traditional static fixation with screws. Purpose: To perform a level 1 meta-analysis of RCTs to investigate the complications, subjective outcomes, and functional results after dynamic or static fixation of acute syndesmotic injuries. Study Design: Meta-analysis of RCTs. Methods: A systematic literature search was performed of the Medline/PubMed, Cochrane Central Register of Controlled Trials, and Embase electronic databases, as well as ClinicalTrials.gov for unpublished studies. Eligible studies were RCTs comparing dynamic fixation and static fixation of acute syndesmosis injuries. A meta-analysis was performed, while bias and quality of evidence were rated according to the Cochrane Database questionnaire and the Grading of Recommendations Assessment, Development and Evaluation guidelines. Results: Dynamic fixation had a significantly reduced relative risk (RR = 0.55, P = .003) of complications—in particular, the presence of inadequate reduction at the final follow-up (RR = 0.36, P = .0008) and the clinical diagnosis of recurrent diastasis or instability (RR = 0.10, P = .03). The effect was more evident when compared with permanent screws (RR = 0.10, P = .0001). The reoperation rate was similar between the groups (RR = 0.64, P = .07); however, the overall risk was reduced after dynamic fixation as compared with static fixation with permanent screws (RR = 0.24, P = .007). The American Orthopaedic Foot & Ankle Society score was significantly higher among patients treated with dynamic fixation—6.06 points higher ( P = .005) at 3 months, 5.21 points ( P = .03) at 12 months, and 8.60 points ( P < .00001) at 24 months—while the Olerud-Molander score was similar. The visual analog scale for pain score was reduced at 6 months (–0.73 points, P = .003) and 12 months (–0.52 points, P = .005), and ankle range of motion increased by 4.36° ( P = .03) with dynamic fixation. The overall quality of evidence ranged from “moderate” to “very low,” owing to a substantial risk of bias, heterogeneity, indirectness of outcome reporting, and evaluation of a limited number of patients. Conclusion: The dynamic fixation of syndesmotic injuries was able to reduce the number of complications and improve clinical outcomes as compared with static screw fixation—especially malreduction and clinical instability or diastasis—at a follow-up of 2 years. A lower risk of reoperation was found with dynamic fixation as compared with static fixation with permanent screws. However, the lack of patients or personnel blinding, treatment heterogeneity, small samples, and short follow-up limit the overall quality of this evidence.


2019 ◽  
Vol 42 (4) ◽  
pp. 434-440 ◽  
Author(s):  
Francesco Bortolotti ◽  
Livia Solidoro ◽  
Maria Lavinia Bartolucci ◽  
Serena Incerti Parenti ◽  
Corrado Paganelli ◽  
...  

Summary Background Surgically assisted rapid maxillary expansion (SARME) is a surgical technique developed to correct transverse discrepancies in skeletally mature patients. However, there is limited evidence concerning the immediate skeletal and dental changes obtained only due to SARME. Objective The aim of the present systematic review is to investigate the immediate skeletal and dental effects of SARME in adult patients with transverse maxillary hypoplasia. Search Methods An electronic search of the literature in MEDLINE, The Cochrane Library, Lilacs and Scopus databases was performed. Selection Criteria Only randomized controlled trials (RCTs) studies investigating the skeletal and dental effects of SARME procedures in adult patients were included. Data Collection and Analysis The included studies received a methodological quality scoring according to the revised Cochrane risk-of-bias tool for randomized trials. The quality of evidence was assessed by means of the Grading Recommendation Assessment, Development and Evaluation (GRADE) system. For each included study and for each analysed parameter, the difference in means and 95 per cent confidence interval was calculated between baseline and immediate post-expansion. A meta-analysis of original outcome data, if possible, was conducted. Results Nine articles were selected. The methodological quality ratings indicated that one study was at low risk of bias, seven presented some concerns and only one was at high risk of bias. In all the included studies, the SARME procedure resulted in a significant expansion of the maxillary transverse dimension. The meta-analysis compared skeletal and dental inter-molar width before and after treatment: the mean difference was of 3.3 mm (2.8–3.9) and 7.0 mm (6.1–7.8), respectively (P-value less than 0.001). The quality of evidence was low-moderate. Conclusions SARME is effective in obtaining a significant expansion of the maxillary transverse dimension. However, the immediate SARME effect is mainly a molar expansion rather than a pure bone transverse widening of the maxilla. Registration The review protocol was registered at PROSPERO database with the registration number CRD42018117967.


2021 ◽  
pp. 204589402110078
Author(s):  
Lu Yan ◽  
Wence Shi ◽  
Zhi-hong Liu ◽  
Qin Luo ◽  
Zhihui Zhao ◽  
...  

Background: Several studies have suggested that exercise capacity and quality of life are reduced in patients with pulmonary hypertension (PH), and exercise-based rehabilitation can improve exercise capacity and quality of life in patients with PH. The aim of this study is to assess the efficacy and safety of exercise-based rehabilitation in patients with PH through a meta-analysis of randomized controlled trials. Methods: We searched PubMed, Embase, Medline, and the Cochrane Central Register of Controlled Trials up to November 2018. All randomized controlled trials (RCTs) comparing exercise capacity and quality of life between patients undergoing exercise-based rehabilitation and those undergoing non-exercise training were included. Data were extracted separately and independently by two investigators, and discrepancies were arbitrated by the third investigator. We used the random-effects model to analyze the results, the GRADE to assess the risk of bias in the included studies, and I ² statistic to estimate the degree of heterogeneity. Results: Nine RCTs are included, however, only seven RCTs were able to extract data. Including inpatients and outpatients, the total number of participants was 234, most of whom were diagnosed as pulmonary artery hypertension (PAH). The study duration ranged from 3 to15 weeks. The mean six-minute walk distance after exercise training was 51.94 metres higher than control (27.65 to 76.23 metres, n=234, 7 RCTs, low quality evidence), the mean peak oxygen uptake  was 2.96 ml/kg/minute higher (2.49 to 3.43 ml/kg/minute, n=179, 4 RCTs, low-quality evidence) than in the control group . Concluded: Our finding suggest that an exercise-based training program positively influences exercise capacity in patients with PH.


2020 ◽  
Author(s):  
Caiyun Zheng ◽  
Hengfen Dai ◽  
Chun Lin ◽  
Yan Zhang ◽  
Hong Zhang ◽  
...  

BACKGROUND An increasing number of patients have received prophylactic or therapeutic oral anticoagulants (OACs) for thromboembolic complications of diseases. The use of OACs is associated with both clinical benefits and risks. Considering the challenges imposed by this class of drugs, as well as the enormous progress made in portable device technology, it is possible that technology-based interventions may improve clinical benefits for patients and optimize anticoagulation management. OBJECTIVE This study was designed to comprehensively evaluate the role of technology-based interventions in the management of OACs. METHODS We searched 6 databases—PubMed, EMBASE, Cochrane, Cumulative Index to Nursing and Allied Health Literature, Scopus, and PsycINFO—to retrieve relevant studies published as of November 1, 2019, to evaluate the effect of technology-based interventions on oral anticoagulation management. RevMan (version 5.3; Cochrane) software was used to evaluate and analyze clinical outcomes. The methodological quality of studies was assessed by the Cochrane risk of bias tool. RESULTS A total of 15 randomized controlled trials (RCTs) were selected for analysis. They reported data for 2218 patients (1110 patients in the intervention groups and 1108 patients in the control groups). A meta-analysis was performed on the effectiveness and safety data reported in the RCTs. Technology-based interventions significantly improved the effectiveness of oral anticoagulation management (mean difference [MD]=6.07; 95% CI 0.84-11.30; I<sup>2</sup>=72%; <i>P</i>=.02). The safety of oral anticoagulation management was also improved, but the results were not statistically significant. Bleeding events were reduced (major bleeding events MD=1.02; 95% CI 0.78-1.32; I<sup>2</sup>=0%; <i>P</i>=.90; minor bleeding events MD=1.06, 95% CI 0.77-1.44; I<sup>2</sup>=41%; <i>P</i>=.73) and thromboembolism events were reduced (MD=0.71; 95% CI 0.49-1.01; I<sup>2</sup>=0%; <i>P</i>=.06). In general, patients were more satisfied with technology-based interventions, which could also improve their knowledge of anticoagulation management, improve their quality of life, and reduce mortality and hospitalization events. CONCLUSIONS Using technology to manage OACs can improve the effectiveness and safety of oral anticoagulation management, result in higher patient satisfaction, and allow greater understanding of anticoagulation.


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