Critical appraisal:Pastorino U, Rossi M, Rosato V, Marchianò A, Sverzellati N, Morosi C, et al 2012
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Article being appraised
Pastorino U, Rossi M, Rosato V, Marchianò A, Sverzellati N, Morosi C, et al. Annual or biennial CT screening versus observation in heavy smokers: 5-year results of the MILD trial. Eur J Cancer Prev 2012 May;21(3):308-15 Available from: http://www.ncbi.nlm.nih.gov/pubmed/22465911.
Applicable clinical question
randomised controlled trial
Number of Patients:
Includes an economic evaluation
Level of evidence
Risk of bias
|Moderate risk of bias||Comments:|
Risk of bias assessment: randomised controlled trial
Was the trial double-blinded?
- Trial was double-blinded but may have limitations (eg method of blinding inappropriate, tablet vs injection with no double-dummy, different treatment schedules, side-effects may unblind)
single-blinded (eg outcomes assessed blind, objective outcomes, no revealing side-effects).
Was the treatment allocation schedule concealed?
- Adequately concealed (e.g. central randomisation, numbered or coded bottles, drugs prepared by pharmacy).
Were all randomised participants included in the analysis?
- No exclusions or survival analysis used with all subjects included (>95% follow-up for all groups).
The field below is not considered when calculating the risk of bias rating
Size of effect
|4||Reason for decision: Both lung cancer specific mortality rates and total mortality rates between control, biennial and annual LDCT screening did not reach a significant difference, with p value of 0.21 and 0.13 respectively.|
Relevance of evidence
|1||Additional comments: lung cancer specific mortality and all causes mortality were both reported.|
Result of appraisal
Associate Professor Eddie Lau FRANZCR, FAANMS
- Pastorino U, Rossi M, Rosato V, Marchianò A, Sverzellati N, Morosi C, et al. Annual or biennial CT screening versus observation in heavy smokers: 5-year results of the MILD trial. Eur J Cancer Prev 2012 May;21(3):308-15 Available from: http://www.ncbi.nlm.nih.gov/pubmed/22465911.
- Assigned to
- Topic area
- Guidelines:Lung cancer/Screening and early detection
- Clinical question
- Study design
- randomised controlled trial
- Level of Evidence
Section below only relevant for Cancer Council Project Officer
The authors stated that this trial is under powered to detect LDCT screening benefit in the order of 10%.
Other useful information from this trial are 1. Selective use of PET decreases surgery for benign nodules to ~9%. 2. Element of overdiagnosis suggested by the annual versus biennial LDCT data. 3. The early pilot data and mortality curve with 10 years follow up did not suggest a protective effect of long term LDCT screening.