Critical Appraisal Athar Yasin EOE - RTD Jan 2012.

Slides:



Advertisements
Similar presentations
Appraisal of an RCT using a critical appraisal checklist
Advertisements

Controversies in the management of Pulmonary Embolism
ATLAS Steering Committee: 24 September 2005 Steering Committee meeting, 24 th September 2005 University of Oxford Examination Schools.
Long-Term Outcome After Additional Catheter-Directed Thrombolysis versus Standard Treatment for Acute Iliofemoral Deep Vein Thrombosis (The CaVenT Study):
EFFICACY AND SAFETY OF RECOMBINANT HUMAN ACTIVATED PROTEIN C FOR SEVERE SEPSIS (PROWESS) GORDONR. BERNARD, M.D. et al. The New England Journal of Medicine.
Journal Club Alcohol, Other Drugs, and Health: Current Evidence July–August 2013.
Consistent Venous Thromboembolism Risk Reduction by Extended- Versus Standard-Duration Enoxaparin Prophylaxis in Subgroups of Acutely Ill Medical Patients.
Study by: Granger et al. NEJM, September 2011,Vol No. 11 Presented by: Amelia Crawford PA-S2 Apixaban versus Warfarin in Patients with Atrial Fibrillation.
Journal Club Alcohol, Other Drugs, and Health: Current Evidence May–June 2013.
1.A 33 year old female patient admitted to the ICU with confirmed pulmonary embolism. It was noted that she had elevated serum troponin level. Does this.
Journal Club Alcohol, Other Drugs, and Health: Current Evidence March–April 2015.
Critical Appraisal of an Article on Therapy (2). Formulate Clinical Question Patient/ population Intervention Comparison Outcome (s) Women with IBS Alosetron.
The Definitive Thrombosis Update
Oral rivaroxaban alone for the treatment of symptomatic pulmonary embolism: the EINSTEIN PE study Harry R Büller on behalf of the EINSTEIN Investigators.
The EINSTEIN PE Study 'Xarelto' for the Acute and Continued Treatment of Symptomatic Pulmonary Embolism.
Neue Antikoagulantien bei spontaner und Tumor-assoziierter VTE Paul Kyrle Univ. Klinik f. Innere Medizin I AKH/Medizinische Universität Wien.
EINSTEIN DVT and EINSTEIN PE Pooled Analysis
JOURNAL REPORT CHOLELITHIASIS PGI Alexander L. Gonzales II DOH – PCSCH 2012.
Day Hospital versus admission for acute psychiatric disorders Dr. Simon Benson ST2 General Practice.
Oral Rivaroxaban for Symptomatic Venous Thrombroenbolism Group /06/11.
EVIDENCE BASED MEDICINE Effectiveness of therapy Ross Lawrenson.
Evidence-Based Journal Article Presentation [Insert your name here] [Insert your designation here] [Insert your institutional affiliation here] Department.
How to Analyze Therapy in the Medical Literature: practical session Akbar Soltani.MD. Tehran University of Medical Sciences (TUMS) Shariati Hospital
ST CATHERINE’S HOSPICE Primary thromboprophylaxis in advanced disease MJ Johnson.
Tissue Plasminogen Activator for Acute Ischemic Stroke National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group.
Rivaroxaban for Prevention of Venous Thromboembolism After Total Knee Arthroplasty: Impact on Healthcare Costs Based on the RECORD3 Study Kwong L, Lees.
1. Title and Abstract Improving abstracts should be a goal not only for authors but also for editors because so few citation browsers ever read more than.
Evidence-Based Medicine Presentation [Insert your name here] [Insert your designation here] [Insert your institutional affiliation here] Department of.
ARISTOTLE Objectives Primary: test for noninferiority of apixaban, a novel oral direct factor Xa inhibitor, versus warfarin Secondary: test for superiority.
What makes difficult asthma difficult? SCH Journal Club Nicki Barker 2012 June 2012 Dysfunctional breathing in children1.
Oral Rivaroxaban for Symptomatic Venous Thromboembolism.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year.
A Randomized Trial of Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism Schulman S et al. Proc ASH 2011;Abstract 205.
Polly Rimtepathip Pharm D. Candidate September 16, 2011 Outpatient Versus Inpatient Treatment for Patients with Acute Pulmonary Embolism: an International,
Etomidate versus ketamine for rapid sequence intubation in acutely ill patients: a multicentre randomised controlled trial. Jabre et al. Lancet 2009;
How to Analyze Therapy in the Medical Literature (part 1) Akbar Soltani. MD.MSc Tehran University of Medical Sciences (TUMS) Shariati Hospital
Higher Incidence of Venous Thromboembolism (VTE) in the Outpatient versus Inpatient Setting Among Patients with Cancer in the United States Khorana A et.
SANOFI-SYNTHELABOARIXTRA ® 1 ARIXTRA ® (fondaparinux sodium) in the prevention of venous thromboembolism after major knee surgery KA Bauer, BI Eriksson,
Critical Appraisal (CA) I Prepared by Dr. Hoda Abd El Azim.
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism 1 (RECORD 1 ) Journal Club General Surgery Rotation.
Sifting through the evidence Sarah Fradsham. Types of Evidence Primary Literature Observational studies Case Report Case Series Case Control Study Cohort.
SANOFI-SYNTHELABOARIXTRA ® 1 ARIXTRA ® (fondaparinux sodium) in the prevention of venous thromboembolism after hip replacement surgery KA Bauer, BI Eriksson,
Applying CRASH-2 (Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage 2) in a Pre- Hospital Wilderness Context Paul B. Jones PGY1.
How to Read a Journal Article. Basics Always question: – Does this apply to my clinical practice? – Will this change how I treat patients? – How could.
Oral Rivaroxaban Compared with Subcutaneous Enoxaparin for Extended Thromboprophylaxis After Total Hip Arthroplasty: The RECORD1 Trial Eriksson BI, Borris.
1 Risk Benefit and Conclusions George Sledge, MD Indiana University School of Medicine.
Clinical Trials The Way We Make Progress Against Disease.
Tinzaparin vs Warfarin for Treatment of Acute Venous Thromboembolism in Patients With Active Cancer Agnes Y. Y. Lee, MD, MSc; Pieter W. Kamphuisen, MD,
CRITICAL APPARAISAL OF A PAPER ON THERAPY 421 CORSE EVIDENCE BASED MEDICINE (EBM)
Critical Appraisal Course for Emergency Medicine Trainees Module 3 Evaluation of a therapy.
2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial Aron Goldhirsch, Richard.
Review on NOACs Studies DR. KOUROSH SADEGHI TEHRAN UNIVERSITY OF MEDICAL SCIENCES.
UOG Journal Club: February 2017
Sample Journal Club Your Name Here.
Evaluating The Accuracy Of International Classification Of Diseases 10TH Revision Codes For Venous Thromboembolism (VTE) And Major Bleeding (MB) in.
Alcohol, Other Drugs, and Health: Current Evidence
Interventional trials
Follow-up and Data Collection
Long-Term Treatment of VTE: Case Studies
Clinical Presentations of VTEa,b NOACs VTE Acute Treatment Trials.
Can we link productivity improvements to patients’ experience and how can we ensure value is as much about experience of care as clinical outcomes?
% Heparin + GPI IIb/IIIa Bivalirudin +
Long-Term Treatment of VTE: Case Studies
Managing Pulmonary Embolism Posthospital Discharge
pulmonary embolism protocol -- EMB review
Incidence of (A) recurrent VTE and (B) major bleeding in select randomised clinical trials of LMWH for the treatment and secondary prevention of VTE in.
Identifying Low-Risk Patients with Pulmonary Embolism Suitable For Outpatient Treatment A VERITY Registry Pilot Study N Scriven, T Farren, S Bacon, T.
Patient flow and outcome in the overtreatment trial
Stavros V. Konstantinides et al. JACC 2017;69:
Standard Protocol Items: Recommendations for Interventional Trials diagram. Standard Protocol Items: Recommendations for Interventional Trials diagram.
Presentation transcript:

Critical Appraisal Athar Yasin EOE - RTD Jan 2012

Lancet 2011;378:41-48 Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial Drahomir Aujesky et al

Summary - Background Management of symptomatic PE is predominantly inpatient based The authors assessed the non-inferiority of outpatient as compared to inpatient care

Summary - Method Adults aged >18 with low risk acute symptomatic objectively verified pulmonary embolism Multi-Centre, Open-label non-inferiority trial Computer generated block randomisation

Summary - Method Primary outcome recurrence of symptomatic objectively confirmed VTE Secondary clinical outcomes Major bleeding within 90 days after randomization All cause mortality within 90 days Other outcomes Patient satisfaction Use of major medical resources Non-inferiority margin of 4% was accepted

Summary-Results Between Feb 2007 – June 2010 randomly allocated 172 patients to each outpatient and inpatient groups 1 (0.6%) patient died in each group p-value outpatient and 2 inpatients were lost to follow up 1 patient (0.6%) in outpatient group had recurrent VTE as compared to none in the inpatient p-value 0.011

Summary - Results 3 patients (1.8%) in the outpatient group had major bleeding with p-value Mean time spend by outpatient group 0.5 days as compared to 3.9 days by inpatients

Summary - Conclusion In low risk patients with PE, outpatient care can safely and effectively carried out in place of the routine inpatient treatment.

Question 2 Define the term randomisation? Has randomisation in the above study worked? This method ensures that each individual entering the study has equal chance of being allocated to any group within the study. Yes – refer to table 2 Computer generated block randomisation

Question 3 Define intention to treat analysis and how is it different to per-protocol analysis? All the study participants are included in the analysis as a part of the groups to which they were allocated, regardless of whether they completed the study or not A per-protocol analysis is an approach used in which data from only those patients who received treatment and complied with the trial protocol are considered in the analysis

Question 4 What is meant by validity? This refers to the extent to which a test measures what it is supposed to measure.

Question 5 Would you change your practice based on the findings of this paper and why / why not? Already started in our set up with few differences SC enoxaparin dosage different to our current practice No intention to treat analysis done