scholarly journals Impact of Outcome Measure and Duration of Follow-up on the Reliability of Clinical Trials Assessing the Efficacy and Safety of Coronary Artery Stents

2018 ◽  
Vol 27 ◽  
pp. S10
Author(s):  
Evelyn Lesiawan ◽  
Ralph Stewart ◽  
Mark Webster
Keyword(s):  
Clinical Trials ◽  
Coronary Artery ◽  
Outcome Measure ◽  
Efficacy And Safety ◽  
Coronary Artery Stents

scholarly journals Movement-Evoked Pain Versus Pain at Rest in Postsurgical Clinical Trials and Meta-Analyses: Protocol for a Follow-Up Systematic Review

10.2196/15309 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e15309
Author(s):  
Daenis Camiré ◽  
Jason Erb ◽  
Henrik Kehlet ◽  
Timothy Brennan ◽  
Ian Gilron
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Postoperative Pain ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Pain Treatment ◽  
Pain Outcome ◽  
Meta Analyses ◽  
Pain At Rest

Background Postoperative pain is one of the most prevalent and disabling complications of surgery that is associated with personal suffering, delayed functional recovery, prolonged hospital stay, perioperative complications, and chronic postsurgical pain. Accumulating evidence has pointed to the important distinction between pain at rest (PAR) and movement-evoked pain (MEP) after surgery. In most studies including both measures, MEP has been shown to be substantially more severe than PAR. Furthermore, as MEP is commonly experienced during normal activities (eg, breathing, coughing, and walking), it has a greater adverse functional impact than PAR. In a previous systematic review conducted in 2011, only 39% of reviewed trials included MEP as a trial outcome and 52% failed to identify the pain outcome as either PAR or MEP. Given the recent observations of postsurgical pain trials that continue to neglect the distinction between PAR and MEP, this updated review seeks to evaluate the degree of progress in this area. Objective This updated review will include postsurgical clinical trials and meta-analyses in which the primary outcome was early postoperative pain intensity. The primary outcome for this review is the reporting of MEP (vs PAR) as an outcome measure for each trial and meta-analysis. Secondary outcomes include whether trials and meta-analyses distinguished between PAR and MEP. Methods To be consistent with the 2011 review that we are updating, this review will again focus on randomized controlled trials and meta-analyses, from Medical Literature Analysis and Retrieval System Online and EMBASE databases, focusing on pain treatment after thoracotomy, knee arthroplasty, and hysterectomy in humans. Trials and meta-analyses will be characterized as to whether or not they assessed PAR and MEP; whether their pain outcome acknowledged the distinction between PAR and MEP; and, for trials assessing MEP, which pain-evoking maneuver(s) were used. Results Scoping review and pilot data extraction are under way, and the results are expected by March 2020. Conclusions It is our belief that every postsurgical analgesic trial should include MEP as an outcome measure. The previous 2011 review was expected to have an impact on more widespread assessment of MEP in subsequent postoperative pain treatment trials. Thus, the purpose of this follow-up review is to reevaluate the frequency of use of MEP as a trial outcome, compared with PAR, in more recently published postoperative pain trials. Trial Registration PROSPERO CRD42019125855; https://tinyurl.com/qw9dty8 International Registered Report Identifier (IRRID) DERR1-10.2196/15309

scholarly journals CRT-100.13 Bioabsorbable Coronary Artery Stents: Patient Follow-up After Two Years Of Treatment

2017 ◽  
Vol 10 (3) ◽  
pp. S8
Author(s):  
Azuolas Sirtautas ◽  
Robertas Pranevicius ◽  
Kasparas Briedis ◽  
Norvydas Zapustas ◽  
Ramunas Unikas ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Coronary Artery Stents

Three-Year Follow-up after Implantation of Metallic Coronary-Artery Stents

1996 ◽  
Vol 334 (9) ◽  
pp. 561-567 ◽  
Author(s):  
Takeshi Kimura ◽  
Hiroyoshi Yokoi ◽  
Yoshihisa Nakagawa ◽  
Takashi Tamura ◽  
Satoshi Kaburagi ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Coronary Artery Stents

scholarly journals Movement-Evoked Pain Versus Pain at Rest in Postsurgical Clinical Trials and Meta-Analyses: Protocol for a Follow-Up Systematic Review (Preprint)

2019 ◽  
Author(s):  
Daenis Camiré ◽  
Jason Erb ◽  
Henrik Kehlet ◽  
Timothy Brennan ◽  
Ian Gilron
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Postoperative Pain ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Pain Treatment ◽  
Pain Outcome ◽  
Meta Analyses ◽  
Pain At Rest

BACKGROUND Postoperative pain is one of the most prevalent and disabling complications of surgery that is associated with personal suffering, delayed functional recovery, prolonged hospital stay, perioperative complications, and chronic postsurgical pain. Accumulating evidence has pointed to the important distinction between pain at rest (PAR) and movement-evoked pain (MEP) after surgery. In most studies including both measures, MEP has been shown to be substantially more severe than PAR. Furthermore, as MEP is commonly experienced during normal activities (eg, breathing, coughing, and walking), it has a greater adverse functional impact than PAR. In a previous systematic review conducted in 2011, only 39% of reviewed trials included MEP as a trial outcome and 52% failed to identify the pain outcome as either PAR or MEP. Given the recent observations of postsurgical pain trials that continue to neglect the distinction between PAR and MEP, this updated review seeks to evaluate the degree of progress in this area. OBJECTIVE This updated review will include postsurgical clinical trials and meta-analyses in which the primary outcome was early postoperative pain intensity. The primary outcome for this review is the reporting of MEP (vs PAR) as an outcome measure for each trial and meta-analysis. Secondary outcomes include whether trials and meta-analyses distinguished between PAR and MEP. METHODS To be consistent with the 2011 review that we are updating, this review will again focus on randomized controlled trials and meta-analyses, from Medical Literature Analysis and Retrieval System Online and EMBASE databases, focusing on pain treatment after thoracotomy, knee arthroplasty, and hysterectomy in humans. Trials and meta-analyses will be characterized as to whether or not they assessed PAR and MEP; whether their pain outcome acknowledged the distinction between PAR and MEP; and, for trials assessing MEP, which pain-evoking maneuver(s) were used. RESULTS Scoping review and pilot data extraction are under way, and the results are expected by March 2020. CONCLUSIONS It is our belief that every postsurgical analgesic trial should include MEP as an outcome measure. The previous 2011 review was expected to have an impact on more widespread assessment of MEP in subsequent postoperative pain treatment trials. Thus, the purpose of this follow-up review is to reevaluate the frequency of use of MEP as a trial outcome, compared with PAR, in more recently published postoperative pain trials. CLINICALTRIAL PROSPERO CRD42019125855; https://tinyurl.com/qw9dty8 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15309

scholarly journals Therapeutic efficacy of alternative primaquine regimens to standard treatment in preventing relapses by Plasmodium vivax: A systematic review and meta-analysis

2015 ◽  
pp. 183-191 ◽  
Author(s):  
Lina Marcela Zuluaga Idarraga ◽  
Maria Eulalia Tamayo Perez ◽  
Daniel Camilo Aguirre Acevedo
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Relative Risk ◽  
Fixed Effects ◽  
Standard Treatment ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Efficacy And Safety ◽  
Standard Regimen

Objective: To compare efficacy and safety of primaquine regimens currently used to prevent relapses by P. vivax. Methods: A systematic review was carried out to identify clinical trials evaluating efficacy and safety to prevent malaria recurrences by P. vivax of primaquine regimen 0.5 mg / kg / day for 7 or 14 days compared to standard regimen of 0.25 mg/kg/day for 14 days. Efficacy of primaquine according to cumulative incidence of recurrences after 28 days was determined. The overall relative risk with fixed-effects meta-analysis was estimated. Results: For the regimen 0.5 mg/kg/day/7 days were identified 7 studies, which showed an incidence of recurrence between 0% and 20% with follow-up 60-210 days; only 4 studies comparing with the standard regimen 0.25 mg/kg/day/14 days and no difference in recurrences between both regimens (RR= 0.977, 95% CI= 0.670 to 1.423) were found. 3 clinical trials using regimen 0.5 mg/kg/day/14 days with an incidence of recurrences between 1.8% and 18.0% during 330-365 days were identified; only one study comparing with the standard regimen (RR= 0.846, 95% CI= 0.484 to 1.477). High risk of bias and differences in handling of included studies were found. Conclusion: Available evidence is insufficient to determine whether currently PQ regimens used as alternative rather than standard treatment have better efficacy and safety in preventing relapse of P. vivax. Clinical trials are required to guide changes in treatment regimen of malaria vivax.

Efficacy and safety of the combination of pertuzumab (P) plus trastuzumab (T) plus docetaxel (D) for HER-2 positive metastatic breast cancer (MBC) in pretreated patients (pts) with trastuzumab in the neo/adjuvant setting: A real-life study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12516-e12516 ◽  
Author(s):  
Giuseppina Ricciardi ◽  
Corrado Ficorella ◽  
Laura Iezzi ◽  
Paolo Marchetti ◽  
Laura Pizzuti ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Metastatic Disease ◽  
Real Life ◽  
Metastatic Breast ◽  
Efficacy And Safety ◽  
Adjuvant Setting ◽  
Her2 Positive ◽  
End Points ◽  
Metastatic Setting

e12516 Background: The discovery of new anti-HER2 targeted therapies has significantly improved the outcomes in the metastatic setting. However, the population enrolled in clinical trials is not always representative of the clinical practice. Moreover, only 7% of breast cancers (BCs) present as metastatic disease at the first clinical observation. In most cases, metastatic disease is diagnosed in pts with a history of BC already treated in the neo/adjuvant setting. This latter subgroup is largely under-represented in clinical trials. The aim of this study was to assess in real-life the efficacy and safety of dual HER2 blockade as 1st line in Trastuzumab-pretreated pts in the neo/adjuvant setting. Methods: This is a multicenter, observational, retrospective study conducted in 6 Oncology Italian Centers. Primary end-points: progression free survival (PFS) and overall survival (OS). Secondary end-points: response rate and cardiac safety. PFS and OS curves were estimated using the Kaplan-Meier method. Tumor response was assessed according to RECIST 1.1 and safety with CTCAE v4.0. Results: We evaluated 35 HER2-positive MBC from November 2013 to December 2016, 60% with tumors Luminal B, 40% HER2-enriched. The most common metastatic sites were: lung (20%), lymph nodes (14.3%) and liver (11.4%). Median (m) age: 50 (range 20-71), mECOG PS 0 (range 0-1). At a m follow-up of 55.6 months (mos) (range 6-170), all pts were evaluable for efficacy and safety. The m number of cycles administrated was 6 (range 2-10). The mPFS was 12 mos (95% CI 2-38). The mOS was 15.2 mos (95% CI 2-36). 14.3% of pts had a complete response, 60% a partial response and 25.7% a stable disease. m baseline LVEF was 65%, final LVEF 61%. Conclusions: Our preliminary data confirmed the efficacy and no increase in cardiac toxicity of the combination Pertuzumab, Trastuzumab and Docetaxel in Trastuzumab-pretreated pts, mirroring the PFS data but not the OS reported in the Cleopatra study. A longer follow-up for OS is needed for a comprehensive evaluation of the antitumor activity of dual-HER2 blockade in Trastuzumab-pretreated pts.

scholarly journals INTEREST GROUP SESSION—GEROSCIENCE: METHODS FROM BENCH TO POPULATION SCIENCE TO INFORM CONSTRUCTION OF GEROSCIENCE CLINICAL TRIALS

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S745-S745
Author(s):  
Jason L Sanders ◽  
Anne B Newman
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Biological Pathway ◽  
Efficacy And Safety ◽  
Population Science ◽  
Multiple Levels ◽  
Aging Mechanisms

Abstract We are on the cusp of a revolution in aging science. It has matured to the point where geroscience trials will test interventions in humans which alter aging mechanisms to lengthen healthspan and possibly lifespan. This goal is unprecedented in clinical trial design, and it requires retooling the clinical trial toolbox. Traditionally, trials are constructed around a single disease; interventions target a narrow part of a defined biological pathway involving only one molecule, tissue, or organ; events are well known intermediate endpoints and clinically-defined hard outcomes; and follow up may be short and historically informed based on prior trials. Geroscience trials by design target aging mechanisms which, when altered, are likely to have pleiotropic effects that modify several biologic pathways; efficacy and safety signals may require integration across multiple levels of biologic organization; intermediate endpoints are not agreed upon; and follow up timelines are undefined. In this symposium, we provide guidance on the design of geroscience trials using examples that span from bench to population science. Dr. LeBrasseur will discuss screening senolytic compounds across models of age-associated decline and advancing their candidacy as interventions. Dr. Justice will detail a framework for biomarker selection in geroscience trials, focusing on a trial of metformin as an example. Dr. Sanders will illustrate how observational data can inform phenotype use in clinical trials. Dr. Levine will explain translating omics data for use in geroscience trials, focusing on epigenomics. We expect additional discussion to hasten development of well-designed geroscience trials.

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