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Cancer Epidemiology, Biomarkers & Prevention
Cancer Epidemiology, Biomarkers & Prevention
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Commentaries

Smoking, The Missing Drug Interaction in Clinical Trials: Ignoring the Obvious

Ellen R. Gritz, Carolyn Dresler and Linda Sarna
Ellen R. Gritz
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Carolyn Dresler
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Linda Sarna
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DOI: 10.1158/1055-9965.EPI-05-0224 Published October 2005
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Tables

  • Table 1.

    Assessment of smoking history, current smoking status, and related behaviors

    {Each question block is a separate module that can be combined with other modules, and the items can be renumbered.}
    Initial Assessment
    1. Have you smoked at least 100 cigarettes in your entire life? (5 packs = 100 cigarettes)
        (a) Yes
        (b) No (If no, this is the end of section) {Code as: Never Smoker}
        (c) Don't know/Not sure
    2. Do you NOW smoke cigarettes?
        (a) Everyday (Skip to item 5)
        (b) Some days (Skip to item 5) {a and b—Code as: Current Smoker}
        (c) Not at all {Code as: Former Smoker}
    3. For how many years did you smoke regularly? ____ {Duration—Former Smoker}
    4. If you do not currently smoke cigarettes but did in the past, how long has it been since you last smoked regularly (i.e., everyday or some days)?
        (a) Within the past month (0-1 month ago)
        (b) Within the past 3 months (1-3 months ago)
        (c) Within the past 6 months (3-6 months ago)
        (d) Within the past year (6-12 months ago)
        {a-d—Code as: Recent Former Smoker}
        (e) Within the past 5 years (1-5 years ago)
        (f) Within the past 15 years (5-15 years ago)
        (g) More than 15 or more ago
        {e-g—Code as: Long-term Former Smoker}
        (h) Don't know/Not sure
        (i) Never smoked regularly
    5. On average, about how many cigarettes a day do (or did) you smoke? (1 pack = 20 cigarettes) _____ cigarettes {Dose}
    6. At what age did you begin smoking regularly? _____ {Age at Initiation}*
    *{To calculate duration for current smokers, subtract age at initiation from current age.}
    Follow-up Assessment
    1. Do you NOW smoke cigarettes?
        (a) Everyday
        (b) Some days {a and b—Code as: Current Smoker}
        (c) Not at all {If you do not smoke cigarettes at all, this is the end of section.} {Code as: Quit}
    2. On average, about how many cigarettes a day do you smoke? (1 pack = 20 cigarettes) _____ cigarettes {Dose}
    Nicotine Dependence
    1. How soon after you wake up do you smoke your first cigarette?
        (a) After 30 minutes
        (b) Within 30 minutes {Code as: Highly Dependent}
    Readiness to Stop Smoking
    1. How many times in the last 12 months have you tried to quit smoking cigarettes and stayed off for at least 24 hours? _____
    2. Are you seriously thinking about quitting in the next month?
        (a) Yes (If yes, this is the end of section) {Code as: Preparation Stage if >1 quit in item 1 or Contemplation Stage if 0 quits in item 1}
        (b) No
    3. Are you seriously thinking about quitting smoking in the next 6 months?
        (a) Yes {Code as: Contemplation Stage}
        (b) No {Code as: Precontemplation Stage}
    Other Forms of Tobacco
    1. Have you ever used other forms of tobacco?
        (a) Yes
        (b) No (If no, this is the end of section)
    2. What other forms of tobacco do (did) you use?
        (a) Pipe
        (b) Cigar
        (c) Chewing tobacco
        (d) Snuff
        (e) Other, specify _____
    3. Do you use other forms of tobacco everyday, some days, or not at all?
        (a) Everyday (This is the end of section)
        (b) Some days (This is the end of section)
        (c) Not at all
    4. If you do not currently use other forms of tobacco but did in the past, how long has it been since you last used other forms of tobacco regularly (i.e., daily)?
        (a) Within the past month (0-1 month ago)
        (b) Within the past 3 months (1-3 months ago)
        (c) Within the past 6 months (3-6 months ago)
        (d) Within the past year (6-12 months ago)
        (e) Within the past 5 years (1-5 years ago)
        (f) Within the past 15 years (5-15 years ago)
        (g) More than 15 years ago
        (h) Don't know/Not sure
        (i) Never smoked regularly
    Exposure to Secondhand Smoke
    1. Do people in your household smoke in the home?
        (a) Yes (If yes, how many? _____)
        (b) No
    2. Is smoking allowed in your workplace?
        (a) Yes
        (b) No
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Cancer Epidemiology Biomarkers & Prevention: 14 (10)
October 2005
Volume 14, Issue 10
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Smoking, The Missing Drug Interaction in Clinical Trials: Ignoring the Obvious
Ellen R. Gritz, Carolyn Dresler and Linda Sarna
Cancer Epidemiol Biomarkers Prev October 1 2005 (14) (10) 2287-2293; DOI: 10.1158/1055-9965.EPI-05-0224

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Smoking, The Missing Drug Interaction in Clinical Trials: Ignoring the Obvious
Ellen R. Gritz, Carolyn Dresler and Linda Sarna
Cancer Epidemiol Biomarkers Prev October 1 2005 (14) (10) 2287-2293; DOI: 10.1158/1055-9965.EPI-05-0224
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  • Article
    • Abstract
    • Introduction
    • Effects of Smoking on Cancer Treatment and Outcome
    • Biological Interactions of Tobacco-Related Carcinogens in Malignant Processes
    • Unexpected Trial Outcomes Related to Smoking
    • Unexplored Topics
    • Recommendations: Including Smoking Data in Clinical Trials
    • Conclusions
    • Footnotes
    • References
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