A journal club evaluation of CT screening for lung cancer disease and an overview about the CT screening.

1. Reduced Lung-Cancer
Mortality with Volume CT
Screening
in a Randomized Trial
Abdulrahman Shaaban
PPE 3-4
Spring 2019-2020
Presented to: Dr. Rima Abdul khalek
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I- General overview about the CT screening
II- Article evaluation:
o Journal
o Title
o Authors
o Funding
o Abstract
o Introduction
o Methods
o Statistical analysis
o Results
o Discussion and Conclusion
o References
III- Related clinical trials
Outline

3. I. General Overview About
The CT Screening
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4. CT Screening
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 It is a process that's used to detect the presence of lung cancer in
otherwise healthy people with a high risk of lung cancer.
 recommended for older adults who are longtime smokers and who
don't have any signs or symptoms of lung cancer.
 Doctors use a low-dose computerized tomography (LDCT) scan of the
lungs to look for lung cancer.

5. Who should consider screening?
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1. Adults > 55 who are current or former smokers.
2. History of smoking for 30 pack years or longer.
3. People who once smoked heavily but quit.
4. History of lung cancer.
5. People with other risk factors for lung cancer ( Family history –
Exposure to asbestos).

6. How long to continue screening
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 In general, continue annual lung cancer screening until you
reach a point at which you're unlikely to benefit from
screening.
 It is a doctor decision.

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9. II. Journal Club Evaluation
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10. • The New England Journal of Medicine (NEJM)
• NEJM publishes weekly: 52 times per week
• Highest impact factor of all general medical journals: 79
• It is a medical journal
Peer reviewed
Well reputable
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11. Title
Reduced Lung-Cancer Mortality with
Volume CT Screening
in a Randomized Trial
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12. Title Evaluation
 Enough information to decide whether to read or not.
Attractive to the reader.
 Study design is mentioned.
 Provide enough information if its about efficacy or safety .
X Biased
X Conclusive.
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13. Authors
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M.D , Ph.D.Harry J. de Koning
• Erasmus MC. Department of Public Health.
• 564 publications.
Ph.D.Carlijn M. van der Aalst
• Erasmus MC. Department of Public Health.
• Senior Research Fellow.
• 63 Publications.
M.D , Ph.D.Pim A. de Jong
• Professor of Radiology.
• Affiliated with Utrecht University.
• 367 publications.

14. Authors Evaluation
 Specialized in the topic.
 Qualified.
 Well reputable.
 Have many publications.
 Have relative publications.
X The authors have affiliations with the pharmaceutical company.
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15. 1. Netherlands Organization of Health
Research and Development.
2. Erasmus MC and University Medical
Center Groningen (UMCG).
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Funding

16. Funding Evaluation
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Risk of
BIAS

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Brief and reflective of the
main ideas.
Provided the reader with
sufficient information to
retrieve the entire article.
Well summarized.
Well structured.
Objective wasn’t clearly
identified.
Methods are clearly described
Results are stated.

18. Introduction
Rationale
• Lung cancer is the leading cause of death from cancer worldwide and
causes more deaths than breast, colorectal, and cervical cancers
combined cancers for which population-based screening programs
exist.
Hypothesis
• Strategy of three annual computed tomographic (CT) screenings
resulted in 20.0% lower mortality from lung cancer than screening
with the use of chest radiography.
Objective
• Reduce the mortality of Lung-Cancer with volume CT screening.
Primary Literature
X Writing of the first draft of the manuscript.
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19. Introduction Evaluation
 Brief introduction.
 Provides Background information about the topic.
 Included rationale and hypothesis.
X Objective is not mentioned clearly.
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20. Methods
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• Subjects: 15,789 patients underwent randomization.
• Sponsors are Identified.
• Study design :Randomly recruited.
• Multicenter(4 sites).

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Inclusion
Criteria
1- inability to climb two flights
of stairs.
2- patient report of moderate
or severe health problems.
3- weight of more than 140 kg.
4- current or past renal cancer.
5- melanoma, or breast cancer.
6- diagnosis of lung cancer or
treatment related to lung
cancer within the past 5 years;
or a chest CT scan within the
past year.
7- A current smoker was
defined as a person who had
smoked cigarettes during the
last 2 weeks.
Exclusion
Criteria
1- current or former smokers [those
who had quit ≤10 years ago] who had
smoked >15 cigarettes a day for >25
years.
2- >10 cigarettes a day for >30 years.

22. Methods Evaluation
The disease was defined clearly and appropriate for inclusion
criteria.
Subjects recruitment does not affect the results: they are randomly
recruited.
Screening is accurately discussed and evaluated.
X Clearly identified why each exclusion criteria was made.
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23. CT Screening
• Low-dose 16-multidetector or, in later rounds, 64-multidetector CT
systems were used to acquire isotropic volume data.
• Four rounds of low-dose CT screening for lung cancer that were
performed in the four CT screening sites with intervals of 1, 2, and 2.5
years.
• Use of semi automated software.
• Segmentation of nodules and determination of the nodule volume.
• If the software was not able to segment a nodule accurately, the
volume was corrected manually by the radiologist.
• Screening could be negative, indeterminate, or positive.
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24. Statistical Methods
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• Intention-to-screen principle.
• Differences in distributions of baseline characteristics of
participants with the use of Pearson’s chi-square test and the
Mann–Whitney test.
• Analyses were performed with the use of Stata software, R
statistical packages, and SPSS software, version 25.

25. Results
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Primary Outcome Secondary Outcome
 lung cancer–specific mortality.  No adverse effects were reported.
Secondary outcomes are not
mentioned.

26. Results
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 Baseline characteristics of male participants did not differ significantly
between the two groups, except for duration of smoking.
 The trial focused on men because smoking was much less
prevalent and much less intensive among women than among
men.
 Because of the importance of the inclusion of women, a sample of
high-risk women was approached for participation.
 The median age of the male participants was 58 years in each group.
 44.9% of the male participants were former smokers.

27. Results Evaluation
 Duration of the trial was sufficient.
 Withdrawals and dropouts are discussed
• 606,409 persons 50 to 74 years of age were approached with a
general questionnaire.
• 30,959 respondents of the 150,920 who returned questionnaires
were eligible.
• 15,822 persons (51.1%), who provided written informed consent,
underwent the initial randomization (13,195 men, 2594 women,
and 3 participants with unknown sex).
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33. Discussion
Study Discussion:
• Volume CT lung-cancer screening of high-risk former and current
smokers resulted in substantially lower lung-cancer mortality (in
both sexes) than no screening.
• More frequent eligibility for curative treatment (mainly surgical).
• Because only modest differences were found between participants
and eligible non-respondents, they expect the results to be highly
generalizable.
• Bias in screening effect in favor of the screening group is therefore
not expected.
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• Potential for overdiagnosis in lung-cancer screening which
indicates that appropriate estimation of the level of
overdiagnosis requires additional years of follow-up.
• Trial data suggest greater benefits in women than in men, but
in a subgroup with a relatively low number of women. More
research is required in women, as well as in other subgroups.
Discussion

35. Discussion
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Student Discussion:
• Strengths and weaknesses are clearly identified.
• Generalization (External Validity) is possible since modest differences
were found between participants and eligible non-respondents.

36. Discussion Evaluation
Summarized the important results.
Discussed the clinical implications.
Stated the limitations of the study.
Did raise a question for further studies
X Compare the results to other published trials.
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37. Conclusion
• Volume CT screening enabled a Significant reduction of harms (e.g.,
false positive tests and unnecessary workup procedures), without
jeopardizing favorable outcomes.
• More research is required in women, as well as in other subgroups.
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40. References Evaluation
38 references.
6 references are outdated.
Authors did not cite themselves excessively.
All references are related to the topic.
Primary and secondary literature were used.
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41. III. Related Clinical Trials
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42. determine whether CT screening
can substantially reduce
mortality related to lung cancer.
CT Screening.
20 lung cancers were detected.
Substantially reduced Lung-
Cancer mortality.
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Volume CT for Diagnosis of Nodules Found in Lung-
Cancer Screening
Objective
Method
Conclusion

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44. - THANK YOU -
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