Dynamic Stabilization of Syndesmosis Injuries Reduces Complications and Reoperations as Compared With Screw Fixation: A Meta-analysis of Randomized Controlled Trials

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Cochrane Central Register of Controlled Trials, and Embase electronic databases, as well as ClinicalTrials.gov for unpublished studies.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.

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A Comprehensive Evaluation Between Dexmedetomidine and Midazolam for Intraoperative Sedation in the Elderly: Protocol for a Systematic Review and Meta-analysis of Randomized Controlled Trials

10.21203/rs.3.rs-864588/v1 ◽

2021 ◽

Author(s):

Chunxia Huang ◽

Zunjiang Li ◽

Yingxin Long ◽

Dongli Li ◽

Manhua Huang ◽

...

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

The Elderly ◽

Sedative Effect ◽

Controlled Trials ◽

Safety And Efficacy ◽

Quality Of Evidence ◽

Randomized Controlled

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).

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Efficacy and Safety of Bevacizumab in the Treatment of Pterygium: An Updated Meta-Analysis of Randomized Controlled Trials

Journal of Ophthalmology ◽

10.1155/2018/4598173 ◽

2018 ◽

Vol 2018 ◽

pp. 1-9 ◽

Cited By ~ 2

Author(s):

Yi Sun ◽

Bowen Zhang ◽

Xiuhua Jia ◽

Shiqi Ling ◽

Juan Deng

Keyword(s):

Randomized Controlled Trials ◽

Meta Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Complication Rates ◽

Efficacy And Safety ◽

Conjunctival Autograft ◽

Randomized Controlled ◽

Significant Difference

Purpose. Studies investigating efficacy and safety of bevacizumab in pterygium have increased and reported controversial results. Thus, we updated this meta-analysis to clarify the issue. Methods. Studies were selected through search of the databases Embase, PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials (CENTRAL) from their inception up until June 2017. The pooled risk ratio (RR) and 95% confidence interval (CI) were calculated for recurrence and complication rates by using random effects model. Results. 1045 eyes in 18 randomized controlled trials (RCTs) enrolled. Overall, the pooled estimate showed a statistically significant effect of bevacizumab on the reduction of recurrence (RR 0.74, 95% CI 0.56–0.97, P=0.03). Subgroup analyses presented significant results beneficial to bevacizumab (primary pterygium group, RR 0.53, 95% CI 0.33–0.83, P=0.006; conjunctival autograft group, RR 0.48, 95% CI 0.25–0.91, P=0.02; and follow-up longer than 12 months group, RR 0.36, 95% CI 0.13–0.99, P=0.05). No statistically significant difference was observed in complication rates. Conclusions. Application of bevacizumab showed a statistically significant decrease in recurrence rate following removal of primary pterygia, or in cases with conjunctival autograft, or with follow-up longer than 12 months, while complications were not increased.

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PRP Injections for the Treatment of Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials

Cartilage ◽

10.1177/1947603520931170 ◽

2020 ◽

pp. 194760352093117 ◽

Cited By ~ 7

Author(s):

Giuseppe Filardo ◽

Davide Previtali ◽

Francesca Napoli ◽

Christian Candrian ◽

Stefano Zaffagnini ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Randomized Controlled Trials ◽

Cochrane Library ◽

Controlled Trials ◽

Quality Of Evidence ◽

Randomized Controlled ◽

Significant Difference ◽

Clinically Significant

Objective To evaluate effectiveness, in terms of patient-reported outcome measures, of platelet-rich plasma (PRP) injections for knee osteoarthritis compared to placebo and other intraarticular treatments. Design PubMed, Cochrane Library, Scopus, Embase, Web of Science, as well as the gray literature were searched on January 17, 2020. Randomized controlled trials (RCTs) comparing PRP injections with placebo or other injectable treatments, in any language, on humans, were included. Risk of bias was assessed following the Cochrane guidelines; quality of evidence was graded using the GRADE guidelines. Results Thirty-four RCTs, including 1403 knees in PRP groups and 1426 in control groups, were selected. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score favored PRP, with a statistically and clinically significant difference versus placebo at 12-month follow-up ( P = 0.02) and versus HA (hyaluronic acid) at 6-month ( P < 0.001) and 12-month ( P < 0.001) follow-ups. A clinically significant difference favoring PRP versus steroids was documented for VAS (Visual Analogue Scale) pain ( P < 0.001), KOOS (Knee Injury and Osteoarthritis Outcome Score) pain ( P < 0.001), function in daily activities ( P = 0.001), and quality of life ( P < 0.001) at 6-month follow-up. However, superiority of PRP did not reach the minimal clinically important difference for all outcomes, and quality of evidence was low. Conclusions The effect of platelet concentrates goes beyond its mere placebo effect, and PRP injections provide better results than other injectable options. This benefit increases over time, being not significant at earlier follow-ups but becoming clinically significant after 6 to 12 months. However, although substantial, the improvement remains partial and supported by low level of evidence. This finding urges further research to confirm benefits and identify the best formulation and indications for PRP injections in knee OA.

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Compound Danshen Dripping Pill for Treating Nonproliferative Diabetic Retinopathy: A Meta-Analysis of 13 Randomized Controlled Trials

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2017/4848076 ◽

2017 ◽

Vol 2017 ◽

pp. 1-10 ◽

Cited By ~ 1

Author(s):

Wenjing Huang ◽

Qi Bao ◽

De Jin ◽

Fengmei Lian

Keyword(s):

Diabetic Retinopathy ◽

Randomized Controlled Trials ◽

Methodological Quality ◽

Vision Loss ◽

Meta Analysis ◽

Controlled Trials ◽

Fundus Fluorescein Angiography ◽

Quality Of Evidence ◽

Randomized Controlled

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.

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Dropout associated with osteopathic manual treatment for chronic noncancerous pain in randomized controlled trials

Journal of Osteopathic Medicine ◽

10.1515/jom-2020-0240 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Yasir Rehman ◽

Hannah Ferguson ◽

Adelina Bozek ◽

Joshua Blair ◽

Ashley Allison ◽

...

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Pooled Analysis ◽

Combination Group ◽

Controlled Trials ◽

Cochrane Central Register ◽

Randomized Controlled ◽

Manual Treatment

Abstract Context Reviews exploring harm outcomes such as adverse effects (AE), all-cause dropouts (ACD), dropouts due to inefficacy, and dropouts due to AE associated with osteopathic manipulative treatment (OMT) or osteopathic manual therapy (OMTh) are scant. Objectives To explore the overall AE, ACD, dropouts due to inefficacy, and AE in chronic noncancerous pain (CNCP) patients receiving OMTh through a systematic review of previous literature. Methods For this systematic review and meta-analysis, the authors searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Physiotherapy Evidence Database (PEDro), EMCare, and Allied and Complementary Medicine Database (AMED), and Ostmed.Dr, as well as the bibliographical references of previous systematic reviews evaluating OMTh for pain severity, disability, quality of life, and return to work outcomes. Randomized controlled trials with CNCP patients 18 years or older with OMTh as an active or combination intervention and the presence of a control or combination group were eligible for inclusion. In this sub-study of a previous, larger systematic review, 11 studies (n=1,015) reported data that allowed the authors to perform meta-analyses on ACD and dropouts due to AE. The risk of bias (ROB) was assessed with the Cochrane ROB tool and the quality of evidence was determined with the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Results The pooled analysis showed that ACD was not significantly different for visceral OMTh (vOMTh) vs. OMTh control (odds ratio [OR]=2.66 [95% confidence interval [[CI]], 0.28, 24.93]) or for OMTh vs. standard care (OR=1.26 [95% CI, 0.84, 1.89]; I2=0%). Single study analysis showed that OMTh results were nonsignificant in comparison with chemonucleolysis, gabapentin, and exercise. OMTh in combination with gabapentin (vs. gabapentin alone) and OMTh in combination with exercise (vs. exercise alone) showed nonsignificant ACD. Dropouts due to AE were not significantly different, but the results could not be pooled due to an insufficient number of studies. Conclusions Most articles did not explicitly report AEs, ACD rates, or dropouts due to AEs and inefficacy. The limited data available on dropouts showed that OMTh was well tolerated compared with control interventions, and that the ACD and dropouts due to AEs were not significantly different than comparators. Future trials should focus on explicit reporting of dropouts along with beneficial outcomes to provide a better understanding of OMTh efficacy.

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Person-Centered Integrated Care for Chronic Kidney Disease

Clinical Journal of the American Society of Nephrology ◽

10.2215/cjn.09960917 ◽

2018 ◽

Vol 13 (3) ◽

pp. 375-386 ◽

Cited By ~ 9

Author(s):

Pim P. Valentijn ◽

Fernando Abdalla Pereira ◽

Marinella Ruospo ◽

Suetonia C. Palmer ◽

Jörgen Hegbrant ◽

...

Keyword(s):

Quality Of Life ◽

Serum Creatinine ◽

Randomized Controlled Trials ◽

Integrated Care ◽

Meta Analysis ◽

Mean Difference ◽

Controlled Trials ◽

Randomized Controlled

Background and objectivesThe effectiveness of person-centered integrated care strategies for CKD is uncertain. We conducted a systematic review and meta-analysis of randomized, controlled trials to assess the effect of person-centered integrated care for CKD.Design, setting, participants, & measurementsWe searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (from inception to April of 2016), and selected randomized, controlled trials of person-centered integrated care interventions with a minimum follow-up of 3 months. Random-effects meta-analysis was used to assess the effect of person-centered integrated care.ResultsWe included 14 eligible studies covering 4693 participants with a mean follow-up of 12 months. In moderate quality evidence, person-centered integrated care probably had no effect on all-cause mortality (relative risk [RR], 0.86; 95% confidence interval [95% CI], 0.68 to 1.08) or health-related quality of life (standardized mean difference, 0.02; 95% CI, −0.05 to 0.10). The effects on renal replacement therapy (RRT) (RR, 1.00; 95% CI, 0.65 to 1.55), serum creatinine levels (mean difference, 0.59 mg/dl; 95% CI, −0.38 to 0.36), and eGFR (mean difference, 1.51 ml/min per 1.73 m2; 95% CI, −3.25 to 6.27) were very uncertain. Quantitative analysis suggested that person-centered integrated care interventions may reduce all-cause hospitalization (RR, 0.38; 95% CI, 0.15 to 0.95) and improve BP control (RR, 1.20; 95% CI, 1.00 to 1.44), although the certainty of the evidence was very low.ConclusionsPerson-centered integrated care may have little effect on mortality or quality of life. The effects on serum creatinine, eGFR, and RRT are uncertain, although person-centered integrated care may lead to fewer hospitalizations and improved BP control.

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Effects of dexamethasone on postoperative cognitive dysfunction and delirium in adults following general anesthesia: a meta-analysis of randomized controlled trials

10.21203/rs.2.362/v1 ◽

2019 ◽

Author(s):

Li-Qin Li ◽

Cong Wang ◽

Mei-Dan Fang ◽

Hong-Yu Xu ◽

Hong-Liu Lu ◽

...

Keyword(s):

Randomized Controlled Trials ◽

General Anesthesia ◽

Cognitive Dysfunction ◽

Meta Analysis ◽

Postoperative Cognitive Dysfunction ◽

Cochrane Library ◽

Controlled Trials ◽

Cochrane Central Register ◽

Randomized Controlled

Abstract Background Several studies have investigated the effects of dexamethasone on postoperative cognitive dysfunction (POCD) or postoperative delirium (POD); however, their conclusions have not been consistent. So we conducted a meta-analysis to determine the effects of dexamethasone on POCD/POD in adults following general anesthesia. Methods Cochrane Central Register of Controlled Trials (CENTRAL, 2018, Issue 11 of 12) in the Cochrane Library (searched November 17, 2018); MEDLINE OvidSP (1946 to November 16, 2018); and Embase OvidSP (1974 to November 16, 2018) were searched for randomized controlled trials that evaluated the incidence of POCD/POD following dexamethasone administration, in adults (age ≥18 years) under general anesthesia. We used the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework to assess the quality of evidence. Results Five studies were included (three studies/1393 participants for the incidence of POCD, and two studies/809 participants for the incidence of POD). There was no significant difference between the dexamethasone group and the placebo group in terms of the incidence of POCD in 30 days after surgery (RR 1.00; 95% CI [0.51, 1.96], P = 1.00, I2 = 77%) or in the incidence of POD (RR 0.95; 95% CI [0.60, 1.50], P = 0.81, I2 = 0%). However, both analyses had some limitations, and we considered the quality of the evidence for the postoperative incidence of POCD and POD to be very low. Conclusions This meta-analysis revealed that prophylactic dexamethasone did not reduce the incidence of POCD and POD. However, additional large high-quality trials are still needed to determine the effects of dexamethasone on the incidence of POCD/POD in patients undergoing surgery.

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Protein Supplementation Under Resistance Training Conditions in Elderly Patients with Sarcopenia: A Meta-analysis of Randomized Controlled Trials

10.21203/rs.3.rs-152067/v1 ◽

2021 ◽

Author(s):

Rui Cheng ◽

Xiao-long Ye ◽

Xu-jun Qin ◽

Yi Wan ◽

Meng Xu

Keyword(s):

Elderly Patients ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Protein Supplementation ◽

Cochrane Library ◽

Controlled Trials ◽

Quality Of Evidence ◽

Randomized Controlled ◽

Significant Difference

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

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

10.1101/100081 ◽

2017 ◽

Author(s):

Devon D. Brewer

Keyword(s):

Randomized Controlled Trials ◽

Trial Design ◽

Meta Analysis ◽

Data Availability ◽

Controlled Trials ◽

Quality Of Evidence ◽

Randomized Controlled ◽

Independent Replication ◽

Design And Methods

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.

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Skeletal and dental effects of surgically assisted rapid palatal expansion: a systematic review of randomized controlled trials

European Journal of Orthodontics ◽

10.1093/ejo/cjz057 ◽

2019 ◽

Vol 42 (4) ◽

pp. 434-440 ◽

Cited By ~ 1

Author(s):

Francesco Bortolotti ◽

Livia Solidoro ◽

Maria Lavinia Bartolucci ◽

Serena Incerti Parenti ◽

Corrado Paganelli ◽

...

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Methodological Quality ◽

Meta Analysis ◽

Transverse Dimension ◽

Risk Of Bias ◽

Controlled Trials ◽

Quality Of Evidence ◽

Randomized Controlled

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.

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