Improving interim decisions in randomized trials by exploiting information on short‐term endpoints and prognostic baseline covariates

2020 ◽  
Vol 19 (5) ◽  
pp. 583-601 ◽  
Author(s):  
Kelly Van Lancker ◽  
An Vandebosch ◽  
Stijn Vansteelandt
Keyword(s):  
Randomized Trials ◽  
Short Term ◽  
Baseline Covariates

scholarly journals Covariate-constrained Randomization Routine for Achieving Baseline Balance in Cluster-randomized Trials

2017 ◽  
Vol 17 (2) ◽  
pp. 503-510 ◽  
Author(s):  
Eva Lorenz ◽  
Sabine Gabrysch
Keyword(s):  
Randomized Trials ◽  
Theoretical Background ◽  
Cluster Randomized Trials ◽  
Cluster Randomized ◽  
Baseline Covariates

In cluster-randomized trials, groups or clusters of individuals, rather than individuals themselves, are randomly allocated to intervention or control. In this article, we describe a new command, ccrand, that implements a covariate-constrained randomization procedure for cluster-randomized trials. It can ensure balance of one or more baseline covariates between trial arms by restriction to allocations that meet specified balance criteria. We provide a brief overview of the theoretical background, describe ccrand and its options, and illustrate it using an example.

scholarly journals Cross-transfer of motor control in visuomotor tasks. Systematic review

2021 ◽  
Vol 38 (5) ◽  
pp. 358-366
Author(s):  
Javier Ruiz-Seijoso ◽  
Yaiza Taboada-Iglesias
Keyword(s):  
Motor Control ◽  
Randomized Trials ◽  
Web Of Science ◽  
Control Group ◽  
Motor Ability ◽  
Short Term ◽  
Exclusion Criteria ◽  
Cross Education ◽  
Visuomotor Tasks ◽  
Visuomotor Skills

Introduction: The term “cross-education” describes the perfomance improvement, both in motor control and strength, of a limb after training the opposite. Despite its current interest, there is no consensus on many concepts of the transfer of a visuomotor skill. The aim of the present research was to review the current literature on the phenomenon of cross-education in visuomotor skills in order to determine the magnitude of transference and its relationships with the context of the intervention. Results: A literature search was conducted during December 2019 in the databases Pubmed, CINAHL, MEDLINE, Web of Science, SPORTdiscus and Scopus. The descriptors “Motor ability” and “Motor skill” were used, in addition to the keywords “Motor control”, “skill”, “Task”, “cross over effect”, “cross exercise”, “contralateral learning”, “inter limb transfer “,” cross transfer “,” cross education “. After applying the inclusion and exclusion criteria, a total of 19 articles were obtained for analysis. Of these articles, 12 are RCTs, 4 crossover clinical trial, 2 are non-randomized trials and only 1 lacks a control group. Most of the articles consist of a short-term intervention. Only 5 studies are of a duration of between 4 and 6 weeks. Conclusion: the cross-education phenomenon occurs in visuomotor skills. However, the magnitude of transference and its relation to the amount of learning of the trained member seems to be very variable depending on the context of the intervention. Likewise, the scarce consensus and the methodological differences in the studies make it difficult to draw firm conclusions about the effects of the context on the transference.

Short-term dialysis catheter versus central venous catheter infections in ICU patients: a post hoc analysis of individual data of 4 multi-centric randomized trials

2019 ◽  
Vol 45 (12) ◽  
pp. 1774-1782 ◽  
Author(s):  
Niccolò Buetti ◽  
Stéphane Ruckly ◽  
Jean-Christophe Lucet ◽  
Olivier Mimoz ◽  
Bertrand Souweine ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Venous Catheter ◽  
Dialysis Catheter ◽  
Individual Data ◽  
Central Venous ◽  
Short Term ◽  
Icu Patients ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
Catheter Infections

Effect of ticagrelor monotherapy on mortality after percutaneous coronary intervention: a systematic review and meta-analysis of randomized trials including 26 143 patients

2020 ◽  
Author(s):  
Sung-Jin Hong ◽  
Chul-Min Ahn ◽  
Jung-Sun Kim ◽  
Byeong-Keuk Kim ◽  
Young-Guk Ko ◽  
...  
Keyword(s):  
Conventional Therapy ◽  
Randomized Trials ◽  
Therapy Group ◽  
Meta Analysis ◽  
Coronary Intervention ◽  
Short Term ◽  
Percutaneous Coronary ◽  
All Cause Mortality ◽  
Conventional Therapy Group ◽  
Type 3

Abstract Aims Optimal timing and strategy of antiplatelet monotherapy after dual-antiplatelet therapy (DAPT) consisting of aspirin and P2Y12 inhibitor for patients who underwent percutaneous coronary intervention (PCI) is still being debated. The aim of this study was to evaluate the effect of ticagrelor monotherapy after short-term DAPT after PCI on mortality. Methods and results A systematic review and meta-analysis was performed using PubMed to search for ticagrelor monotherapy after short-term DAPT comparing conventional DAPT in patients who underwent PCI. Three randomized trials encompassing 26 143 patients [ticagrelor monotherapy after 1–3 months of DAPT (n = 13 062) vs. conventional therapy (n = 13 081)] were included. The efficacy endpoint of all-cause mortality was significantly lower with the ticagrelor monotherapy group vs. the conventional therapy group [risk ratio (RR) = 0.80, 95% confidence interval (CI) 0.65–0.98; P = 0.03; I2 = 0%; number needed to treat for benefit (NNTB) = 320]. The safety endpoint of Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding was also significantly lower with the ticagrelor monotherapy group vs. the conventional therapy group (RR = 0.67, 95% CI 0.49–0.92; P = 0.01; I2 = 65%; NNTB = 156). There were no significant differences in ischaemic stroke, acute myocardial infarction, and stent thrombosis. The favourable effects of the ticagrelor monotherapy vs. the conventional therapy on all-cause mortality and BARC type 3 or 5 bleeding were consistent in the subset of patients presenting acute coronary syndromes (n = 15 157). Conclusion Ticagrelor monotherapy after short-term DAPT of 1–3 months was associated with decreased all-cause mortality and BARC type 3 or 5 bleeding not offset by increase of cardiac death, ischaemic stroke, acute myocardial infarction, and stent thrombosis.

scholarly journals Effect of Therapeutic Exercise on Pain and Disability in the Management of Chronic Nonspecific Neck Pain: Systematic Review and Meta-Analysis of Randomized Trials

2013 ◽  
Vol 93 (8) ◽  
pp. 1026-1036 ◽  
Author(s):  
Lucia Bertozzi ◽  
Ivan Gardenghi ◽  
Francesca Turoni ◽  
Jorge Hugo Villafañe ◽  
Francesco Capra ◽  
...  
Keyword(s):  
Neck Pain ◽  
Randomized Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Relevant Literature ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Therapeutic Exercise ◽  
Short Term ◽  
Evidence Database

BackgroundGiven the prevalence of chronic nonspecific neck pain (CNSNP) internationally, attention has increasingly been paid in recent years to evaluating the efficacy of therapeutic exercise (TE) in the management of this condition.PurposeThe purpose of this study was to conduct a current review of randomized controlled trials concerning the effect of TE on pain and disability among people with CNSNP, perform a meta-analysis, and summarize current understanding.Data SourcesData were obtained from MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE, Physiotherapy Evidence Database (PEDro), and Cochrane Central Register of Controlled Trials (CENTRAL) databases from their inception to August 2012. Reference lists of relevant literature reviews also were tracked.Study SelectionAll published randomized trials without any restriction regarding time of publication or language were considered for inclusion. Study participants had to be symptomatic adults with only CNSNP.Data ExtractionTwo reviewers independently selected the studies, conducted the quality assessment, and extracted the results. Data were pooled in a meta-analysis using a random-effects model.Data SynthesisSeven studies met the inclusion criteria. Therapeutic exercise proved to have medium and significant short-term and intermediate-term effects on pain (g=−0.53, 95% confidence interval [CI]=−0.86 to −0.20, and g=−0.45, 95% CI=−0.82 to −0.07, respectively) and medium but not significant short-term and intermediate-term effects on disability (g=−0.39, 95% CI=−0.86 to 0.07, and g=−0.46, 95% CI=−1.00 to −0.08, respectively).LimitationsOnly one study investigated the effect of TE on pain and disability at follow-up longer than 6 months after intervention.ConclusionsConsistent with other reviews, the results support the use of TE in the management of CNSNP. In particular, a significant overall effect size was found supporting TE for its effect on pain in both the short and intermediate terms.

scholarly journals Assessing Short-term Deterioration in Maintenance-naïve Patients with COPD Receiving Umeclidinium/Vilanterol and Tiotropium: A Pooled Analysis of Three Randomized Trials

2016 ◽  
Vol 33 (12) ◽  
pp. 2188-2199 ◽  
Author(s):  
M. Reza Maleki-Yazdi ◽  
Dave Singh ◽  
Antonio Anzueto ◽  
Lee Tombs ◽  
William A. Fahy ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Pooled Analysis ◽  
Short Term

scholarly journals Systematic Review of Effectiveness and Complications of Adhesiolysis in the Management of Chronic Spinal Pain: An Update

2007 ◽  
Vol 1;10 (1;1) ◽  
pp. 129-146
Author(s):  
Andrea M Trescot
Keyword(s):  
Systematic Review ◽  
Low Back Pain ◽  
Back Pain ◽  
Lower Extremity ◽  
Randomized Trials ◽  
Spinal Pain ◽  
Low Back ◽  
Short Term ◽  
Lower Extremity Pain

Background: Percutaneous epidural adhesiolysis and spinal endoscopic adhesiolysis are interventional pain management techniques used to treat patients with refractory low back pain due to epidural scarring. Standard epidural steroid injections are often ineffective, especially in patients with prior back surgery. Adhesions in the epidural space can prevent the flow of medicine to the target area; lysis of these adhesions can improve the delivery of medication to the affected areas, potentially improving the therapeutic efficacy of the injected medications. Study Design: A systematic review utilizing the methodologic quality criteria of the Cochrane Musculoskeletal Review Group for randomized trials and the criteria established by the Agency for Healthcare Research and Quality (AHRQ) for evaluation of randomized and non-randomized trials. Objective: To evaluate and update the effectiveness of percutaneous adhesiolysis and spinal endoscopic adhesiolysis in managing chronic low back and lower extremity pain due to radiculopathy, with or without prior lumbar surgery, since the 2005 systematic review. Methods: Basic search identified the relevant literature, in the MEDLINE, EMBASE, and BioMed databases (November 2004 to September 2006). Manual searches of bibliographies of known primary and review articles, and abstracts from scientific meetings within the last 2 years were reviewed. Randomized and non-randomized studies are included in the review based on criteria established. Percutaneous adhesiolysis and endoscopic adhesiolysis are analyzed separately. Outcome Measures: The primary outcome measure was significant pain relief (50% or greater). Other outcome measures were functional improvement, improvement of psychological status, and return to work. Short-term relief was defined as less than 3 months, and long-term relief was defined as 3 months or longer. Results: Studies regarding the treatment of epidural adhesions for the treatment of low back and lower extremity pain were sought and reviewed. The evidence from the previous systematic review was combined with new studies since November 2004. There is strong evidence for short term and moderate evidence for long term effectiveness of percutaneous adhesiolysis and spinal endoscopy. Conclusion: Percutaneous adhesiolysis and spinal endoscopy may be effective interventions to treat low back and lower extremity pain caused by epidural adhesions. Key Words: Spinal pain, chronic low back pain, percutaneous adhesiolysis, spinal endoscopic adhesiolysis, spinal stenosis, post lumbar laminectomy syndrome, epidural fibrosis, epidural adhesions, caudal neuroplasty.

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