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