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www.alcoholandhealth.org 1
Journal Club
Alcohol and Health: Current EvidenceSeptember–October 2006
www.alcoholandhealth.org 2
Featured Article
Comparison of the combined marker GGT-CDT and the conventional laboratory markers of alcohol
abuse in heavy drinkers, moderate drinkers and abstainers
Hietala J, et al. Alcohol Alcohol. Advance Access published on June 23, 2006; doi:10.1093/alcalc/agl050.
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Study Objective
• To assess whether combining gamma-glutamyltransferase (GGT) and carbohydrate-deficient transferrin (CDT) (GGT-CDT) is…
• better than using single biomarkers to detect heavy drinking
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Study Design
• Markers compared in the following 3 groups:
– 165 heavy drinkers* with alcohol dependence– 51 moderate drinkers– 35 abstainers
• 51 heavy drinkers had evidence of liver disease but not hepatitis B or C.
• 44 heavy drinkers were later assessed during supervised abstinence.
*Drank approximately 3–40 drinks per day
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Assessing Validity of an Article About Diagnostic
Tests
• Are the results valid?
• What are the results?
• Will the results help me in caring for my patients?
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Are the Results Valid?
• Was there an independent, blind comparison with a reference standard?
• Did the patient sample include an appropriate spectrum of patients to whom the diagnostic test will be applied in clinical practice?
• Did the results of the test being evaluated influence the decision to perform the reference standard?
• Were the methods for performing the test described in sufficient detail to permit replication?
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Was there an independent, blind comparison with a reference
standard?• Reference standard for heavy drinking:
– Alcohol consumption in heavy drinkers was determined by detailed interview using a Timeline Follow-back technique (a validated method).
– Consumption in moderate drinkers was determined by an unspecified questionnaire.
• Blinding:
– Blinding is not specified.
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Did the patient sample include an appropriate spectrum of patients to
whom the diagnostic test will be applied in clinical practice?
• The sample included heavy drinkers with alcohol dependence with and without liver disease, moderate drinkers, and abstainers.
• However…
– none of the subjects had hepatitis B or C, – the entire sample included only 38 women, – all heavy drinkers drank heavily frequently, and– most importantly, no heavy drinkers without
dependence were included.
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Did the results of the test being evaluated influence the decision
to perform the reference standard?
• The sequence of events is not specified.
• Both the evaluated test and reference standard were administered to all subjects included in this report.
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Were the methods for performing the test described in sufficient detail to permit
replication?
• Yes.
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What Are the Results?
• Are the likelihood ratios for the test results presented or data necessary for their calculation included?
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Are the likelihood ratios for the test results presented or data necessary for their calculation
included?• Yes:
– The sensitivity of GGT-CDT for detecting heavy drinking was 90% (specificity 98%) and exceeded that of the other biomarkers:
• 63% for CDT alone • 58% for GGT alone • 50% for alanine aminotransferase • 47% for aspartate aminotransferase • 45% for mean corpuscular volume
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Likelihood ratios for the test results (cont.)
• A positive GGT-CDT test had a likelihood ratio (LR) of 45 for heavy drinking.
• A negative GGT-CDT test had an LR of 0.1 for heavy drinking.
• The superior performance of GGT-CDT was not affected by the presence of liver disease.
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Will the Results Help Me in Caring for my Patients?
• Will the reproducibility of the test result and its interpretation be satisfactory in my setting?
• Are the results applicable to my patients?
• Will the results change my management strategy?
• Will patients be better off as a result of the test?
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Will the reproducibility of the test result and its interpretation
be satisfactory in my clinical setting?
• The GGT and CDT can be performed as described in the paper, and a formula for their combination is specified.
• The precision and accuracy of the test in this study
were provided and could be assessed locally.
• Thus, the reproducibility and interpretation could be satisfactory in settings that follow the same procedures.
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Are the results applicable to the patients in my practice?
• No detail regarding the practice setting is provided.
• Therefore, applicability is questionable or, at least, difficult to determine.
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Will the results change my management strategy?
• This study does not address how these tests should be integrated into practice.
– E.g., when should they be used in addition to or in lieu of questionnaires?
• As such, this study alone is unlikely to
change management strategies, though it does suggest the combined biomarker is more accurate than single blood tests.
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Will patients be better off as a result of the test?
• Since the study does not have management implications,…
– it is not clear whether patients will be better off.
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Summary/Clinical Resolution
• Combining biomarkers may be more fruitful than individual serum tests for detecting heavy drinking.
• This study has a number of limitations:
– Recruitment/subject sampling and selection details are not provided, making generalizability difficult to determine.
– The spectrum of subjects was limited, threatening validity.
– Blinding was not specified, and therefore not likely done.
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Summary/Clinical Resolution (cont.)
• Limitations (cont.):
– It is unknown whether some subjects who did not get the reference standard were excluded.
• Many questions remain about using combined biomarkers in clinical settings, such as…
– when they should be used instead of or in addition to questionnaires.