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  • Enhancing the Scientific Integrity and Safety of Clinical Trials: Recommendations for Data Monitoring Committees

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    JAMA. 2016; 316(22):2359-2360. doi: 10.1001/jama.2016.16070

    This Viewpoint discusses the roles of data monitoring committees (DMCs) in providing oversight of clinical trials and summarizes recommendations from the Clinical Trials Transformation Initiative for improving this oversight as a means of improving DMC processes and effectiveness.

  • Data and Safety Monitoring Boards: Academic Credit Where Credit Is Due?

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    JAMA. 2013; 310(15):1563-1564. doi: 10.1001/jama.2013.280383
  • Reporting of Noninferiority and Equivalence Randomized Trials: Extension of the CONSORT 2010 Statement

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    JAMA. 2012; 308(24):2594-2604. doi: 10.1001/jama.2012.87802
    To improve reporting and interpretation of noninferiority and equivalence trials, Piaggio and coauthors present and discuss an updated extension of the CONSORT checklist based on the 2010 version of the CONSORT Statement and the 2008 CONSORT Statement for the reporting of abstracts.
  • JAMA October 17, 2012

    Figure: Study Flow of Patients

    All 3418 patients randomized were included in the primary analysis.aReasons for exclusion do not sum to 428 because patients could be excluded for more than 1 reason.bAs recommended by the data and safety monitoring board, all patients received standard-dose multivitamin supplements between November 30, 2007, and March 16, 2008.
  • Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010

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    JAMA. 2012; 307(17):1838-1847. doi: 10.1001/jama.2012.3424
    Califf and coauthors analyzed characteristics of 96 346 clinical studies registered in ClinicalTrials.gov between October 2004 and September 2007, including the trial sponsors; sizes; and whether randomization, blinding, and data monitoring committees were used. In an Editorial, Dickersin and Rennie trace the evolution of trial registries and some issues with the current registration system.
  • JAMA November 9, 2011

    Figure 2: Carotid Occlusion Surgery Study (COSS) Flow Diagram

    The 10 most common reasons recorded for failure of screened participants to meet clinical eligibility criteria were as follows: transient ischemic attack or stroke not in territory of occluded carotid artery (n = 1597), transient ischemic attack or stroke not within preceding 120 days (n = 485), language comprehension not intact (n = 283), nonatherosclerotic condition causing carotid artery occlusion (n = 280), modified Barthel Index not ≥12/20 (n = 168), unsuitable surgical candidate (n = 160), no occlusion of 1 internal carotid artery (n = 114), not competent to give informed consent (n = 110), subsequent surgery planned that might alter cerebral hemodynamics (n = 105), age not 18-85 years (n = 104). For each screened participant, only 1 reason needed to be provided. PET indicates positron emission tomography; EC-IC, extracranial-intracranial; DSMB, data and safety monitoring board.
  • When Should Data and Safety Monitoring Committees Share Interim Results in Cardiovascular Trials?

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    JAMA. 2008; 299(14):1710-1712. doi: 10.1001/jama.299.14.1710
  • Randomized Trials Stopped Early for Benefit: A Systematic Review

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    JAMA. 2005; 294(17):2203-2209. doi: 10.1001/jama.294.17.2203
  • Authorship for Research Groups

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    JAMA. 2002; 288(24):3166-3168. doi: 10.1001/jama.288.24.3166
  • Effect of Dexmedetomidine Added to Standard Care on Ventilator-Free Time in Patients With Agitated Delirium: A Randomized Clinical Trial

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    JAMA. 2016; 315(14):1460-1468. doi: 10.1001/jama.2016.2707

    This randomized clinical trial assesses the effectiveness of dexmedetomidine when added to standard care in patients with agitated delirium receiving mechanical ventilation.

  • Early Parenteral Nutrition in Critically Ill Patients With Short-term Relative Contraindications to Early Enteral Nutrition: A Randomized Controlled Trial

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    JAMA. 2013; 309(20):2130-2138. doi: 10.1001/jama.2013.5124
    Doig and coauthors investigated outcomes for adult patients in intensive care units who received early parenteral nutrition because of relative contraindications to early enteral nutrition. The multicenter, randomized, single-blind clinical trial included 1372 patients in 31 community and tertiary hospitals in Australia and New Zealand.
  • Initial Trophic vs Full Enteral Feeding in Patients With Acute Lung Injury: The EDEN Randomized Trial

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    JAMA. 2012; 307(8):795-803. doi: 10.1001/jama.2012.137
  • Regimen Simplification to Atazanavir-Ritonavir Alone as Maintenance Antiretroviral Therapy After Sustained Virologic Suppression

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    JAMA. 2006; 296(7):806-814. doi: 10.1001/jama.296.7.806
  • Effect of Evidence-Based Feeding Guidelines on Mortality of Critically Ill Adults: A Cluster Randomized Controlled Trial

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    JAMA. 2008; 300(23):2731-2741. doi: 10.1001/jama.2008.826
  • Dual vs Single Protease Inhibitor Therapy Following Antiretroviral Treatment Failure: A Randomized Trial

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    JAMA. 2002; 288(2):169-180. doi: 10.1001/jama.288.2.169
  • Nucleoside Analogs Plus Ritonavir in Stable Antiretroviral Therapy–Experienced HIV-Infected Children: A Randomized Controlled Trial

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    JAMA. 2000; 283(4):492-498. doi: 10.1001/jama.283.4.492
  • Effect of Not Monitoring Residual Gastric Volume on Risk of Ventilator-Associated Pneumonia in Adults Receiving Mechanical Ventilation and Early Enteral Feeding: A Randomized Controlled Trial

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    JAMA. 2013; 309(3):249-256. doi: 10.1001/jama.2012.196377
    In a randomized trial, Reignier and coauthors assess the risk that ventilator-associated pneumonia (VAP) is not increased when residual gastric volume is not monitored vs routine monitoring in 452 patients receiving invasive mechanical ventilation and early enteral nutrition. In an Editorial, Rice discusses enteral feeding in critically ill patients.
  • Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial

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    JAMA. 2017; 318(6):536-547. doi: 10.1001/jama.2017.9479

    This randomized clinical trial compares the efficacy and adverse effects of 2 cerebral embolic protection devices vs a shared control group in reducing ischemic central nervous system injury during surgical aortic valve replacement.

  • Effect of Hydrocortisone on Development of Shock Among Patients With Severe Sepsis: The HYPRESS Randomized Clinical Trial

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    JAMA. 2016; 316(17):1775-1785. doi: 10.1001/jama.2016.14799

    This randomized clinical trial compares the effects of hydrocortisone vs placebo on development of septic shock among intensive care patients with severe sepsis who were not in septic shock.

  • Effect of Creatine Monohydrate on Clinical Progression in Patients With Parkinson Disease: A Randomized Clinical Trial

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    JAMA. 2015; 313(6):584-593. doi: 10.1001/jama.2015.120

    This randomized clinical trial determined that treatment with creatine monohydrate for at least 5 years did not improve clinical outcomes in patients with early Parkinson disease.