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Effect of a 3-step Critical Pathway to Reduce Duration of IV Antibiotics and Length of Stay in CAP

Effect of a 3-step Critical Pathway to Reduce Duration of IV Antibiotics and Length of Stay in CAP. Sapna Girdharilal Sep 2013. Published in JAMA Internal Medicine in June 2012 Study conducted in 2 Tertiary hospitals in Barcelona,Spain Prospective Randomised Controlled Trial. Background.

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Effect of a 3-step Critical Pathway to Reduce Duration of IV Antibiotics and Length of Stay in CAP

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  1. Effect of a 3-step Critical Pathway to Reduce Duration of IV Antibiotics and Length of Stay in CAP Sapna Girdharilal Sep 2013

  2. Published in JAMA Internal Medicine in June 2012 • Study conducted in 2 Tertiary hospitals in Barcelona,Spain • Prospective Randomised Controlled Trial

  3. Background • Big percentage of population develop CAP • Many patients require admission • LOS related to expenditure • LOS also related to complications • Physicians do not have uniform discharge criteria • Duration of IV Antibiotics related to LOS

  4. Background contd.. • Primary endpoint – LOS • Secondary endpoints included • Duration of iv antibiotic therapy • Adverse drug reactions • Readmission rate • Overall case fatality rate • Patient satisfaction

  5. Methods • Prospective RCT • 2 tertiary hospitals in Barcelona,Spain between 01,May 2005 – 31,Dec 2007 • Ethics Committee approval was obtained

  6. Recruitment • Inclusion criteria included • Patients older than 18 years • CAP diagnosed on the basis of Chest infiltrates on CXR, Fever >38 C or <35 C , Cough with or without sputum, pleuritic chest pain, Dyspnoea, Altered breath sounds • Pneumonia severity index classes IV, V

  7. Recruitment contd.. • In addition a patient with Pneumonia severity index of I,II,III with a PaO2 <60mmHg,SpO2<90%,Temp >37.8,HR >100,Sys BP <90 • Previous Antibiotic therapy for >48 hours • Metastatic infection • Concomitant unstable comorbidities

  8. Exclusion criteria • If 2 or more of the following present • ICU/Moribund • Shock • Large pleural effusion or Empyema • Pregnant • Aspiration Pneumonia • Severe social problems

  9. Randomisation • Epidemiologist generated the random allocation sequence • In the ED patients who met the criteria were recruited to the trial • Informed consent was obtained • Randomly assigned to a 3-step pathway • Physicians split into 2 groups by epidemiologist • Each group deals with a different limb of trial

  10. 3 – step pathway • Early mobilisation • Objective criteria to switch from iv to oral antibiotics based on Temp, RR, BP, vasopressors • Predefined criteria for discharge based on oral antibiotics, mental status,PaO2 on room air • Antibiotics were standardised based on hospital policy

  11. Data collection • Collected daily by investigators. • Included primary and secondary outcomes • Duration of IV antibiotics used • Patients reviewed at 30 days to assess patient satisfaction, readmissions • Case fatality rates

  12. Statistics • Sample size estimated at 380 patients to achieve 82% power and 5% significant levels using paired t-tests and 1.5 day difference in LOS • If 5% may not be evaluable group size of 200 each would be required • Descriptive statistics for all variables • Continuous variables compared using Mann-Whitney test

  13. Results • LOS -4 days • IV therapy – 2 days • Drug reactions- 4.5% • Complications - 20% • Readmissions – 9% • Case fatality – 2% • LOS – 6 days • IV therapy – 4 days • Drug reactions – 15.9% • 24.4% • 7.5% • 1%

  14. Conclusion • Well conducted and powered study.However has some problems with randomisation and blinding which may have contributed to their outcomes. • Overall validity may be questionable.

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