Critical appraisal:Price A, Yellowlees A, Keerie C, Russell S, Faivre-Finn C, Gilligan D, et al 2012 3
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This appraisal has been completed.
- Article
- Price A, Yellowlees A, Keerie C, Russell S, Faivre-Finn C, Gilligan D, et al. Radical radiotherapy with or without gemcitabine in patients with early stage medically inoperable non-small cell lung cancer. Lung Cancer 2012 Sep;77(3):532-6 Available from: http://www.ncbi.nlm.nih.gov/pubmed/22672970.
- Assigned to
- User:Chris.karapetis
- Topic area
- Guidelines:Lung cancer
- Clinical question
- Study design
- randomised controlled trial - Cochrane tool
- Level of Evidence
- II
Section below only relevant for Cancer Council Project Officer
Critical Appraisal
Article being appraised
Price A, Yellowlees A, Keerie C, Russell S, Faivre-Finn C, Gilligan D, et al. Radical radiotherapy with or without gemcitabine in patients with early stage medically inoperable non-small cell lung cancer. Lung Cancer 2012 Sep;77(3):532-6 Available from: http://www.ncbi.nlm.nih.gov/pubmed/22672970.
Applicable clinical question
Key Facts
Study Design
randomised controlled trial - Cochrane tool
Study aims:
Demonstrate that the addition of chemotherapy to radical radiotherapy improves outcomes for patients with inoperable stage I NSCLC
Number of Patients:
111
T1--2, N0-1, M0 NSCLC
Not fit for surgery
Not fit for surgery
Reported outcome(s):
Event free Survival - no difference between the 2 arms
Results of outcome(s):
No difference in EFS between the 2. Arms
Includes an economic evaluation
no
Evidence ratings
Level of evidence
II
Risk of bias
| Low risk of bias | Comments: Please replace this text and include any additional comments in regards to your risk of bias rating |
Risk of bias assessment: Randomised Controlled Trial (Cochrane risk of bias tool)
Random sequence generation
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
- Telephone randomisation with no stratification
What was the risk of bias from the random sequence generation?
- Low
Allocation concealment
Describe the method used to conceal the allocation sequence in sufficient detail to determine whether intervention allocations could have been foreseen in advance of or during, enrolment.
- Randomisation via a 3rd party/outside trial centre (telephone)
What was the risk of bias from the allocation concealment?
- Low
Blinding
Describe all measures used, if any, to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
- No blinding
- may affect PFS but not OS
What was the risk of bias from the blinding of participants and personnel and outcome assessors?
- Unclear
Incomplete outcome data
Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
- 111 patients were randomised and 107 were evaluated
What was the risk of bias from incomplete outcome data?
- Low
Selective outcome reporting
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
What was the risk of bias from selective outcome reporting? Assessments should be made for each main outcome (or class of outcomes).
- Low
Other sources of bias
Describe any other sources of bias
- PFS as an endpoint is subject to reporting bias when assessed by the investigator
What was the risk of bias from other sources?
- Unclear
Size of effect
| 2 | Reason for decision: Small sample size. Small but significant benefit may be missed. |
Relevance of evidence
| 1 | Additional comments: Evaluate survival |
Result of appraisal
Included
Completed by