Randomised control trial
Christ-Crain M, Jaccard-Stolz D, Bingisser R et alEffect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomized single-blinded intervention trial
Lancet
2004;363:600-607
- Submitted by:Kevin Mackway-Jones - Professor in Emergency Medicine
- Institution:Manchester Royal Infirmary
- Date submitted:12th March 2004
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes: To assess the capability of a sensitive procalcitonin assay to identify bacterial lower respiratory tract infections needing antimicrobial treatment
2
Design
2.1
Is the study design suitable for the objectives
Yes
2.2
Who / what was studied?
Patients attending the Emergency department of the University Hospital in Basel between 16.12.02 1nd 13.04.03 with cough, dyspnoea (or both)
2.3
Was this the right sample to answer the objectives?
Yes
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
Yes. 95% power to detect a 30% reduction in antibiotic exposure
2.5
Were all subjects accounted for?
Yes. CONSORT given (P 601)
2.6
Were all appropriate outcomes considered?
Yes.
Primary: Antibiotic use (% patients and patient days)
Secondary: QALIs, LoS, biocem markers, death etc
Primary: Antibiotic use (% patients and patient days)
Secondary: QALIs, LoS, biocem markers, death etc
2.7
Has ethical approval been obtained if appropriate?
Yes
2.8
Were the patients randomised between treatments?
Yes.
2.9
How was randomisation carried out?
Computer generated weekwise-randomization scheme
2.10
Are the outcomes clinically relevant?
Yes
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
Yes. Covered in detail P 601-3
3.2
Are the measurements valid?
Yes
3.3
Are the measurements reliable?
Yes
3.4
Are the measurements reproducible?
Yes
3.5
Were the patients and the investigators blinded?
Single-blinded (patients). The treating physician made a comment about intention to prescribe antibiotics prior to being informed of procalcitonin result (if in a procalcitonin week)
4
Presentation of results
4.1
Are the basic data adequately described?
Yes. Comprehensive table 1 (p 602)
4.2
Were groups comparable at baseline?
Yes
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
Yes
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
Yes
4.5
Were side effects reported?
Yes. Deaths are reported in detail (p 605)
Physician overide is discussed (9 antibiotic prescriptions when not required and 13 when not advised)
Physician overide is discussed (9 antibiotic prescriptions when not required and 13 when not advised)
5
Analysis
5.1
Are the data suitable for analysis?
Yes
5.2
Are the methods appropriate to the data?
Yes
5.3
Are any statistics correctly performed and interpreted?
yes
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
Yes
6.2
Is the discussion biased?
No. Clear balance and suitably guarded
7
Interpretation
7.1
Are the authors' conclusions justified by the data?
Yes
7.2
What level of evidence has this paper presented? (using CEBM levels)
1 b - single randomized trial with narrow confidence intervals
7.3
Does this paper help me answer my problem?
Yes
8
Implementation
8.1
Can any necessary change be implemented in practice?
Dependant on laboratory availability and speed of result delivery. Best in a clinical decision environment
8.2
What aids to implementation exist?
Clinical decision unit algorithms
8.3
What barriers to implementation exist?
Change to current practice