1 Department of General Practice, Division of Clinical Methods and Public Health and 2 Dutch Cochrane Centre, Academic Medical Center University of Amsterdam, Amsterdam, 3 Addiction Research Institute, Rotterdam, 4 General Practitioner, Purmerend, 5 Department of General Practice, Leiden University Medical Center, Leiden, The Netherlands
* Author to whom correspondence should be addressed at: Academic Medical Center, University of Amsterdam, Division of Clinical Methods and Public Health, Department of General Practice, PO Box 22700, 1100 DE, Amsterdam, The Netherlands. Tel.: +31 20 566 3065; Fax: +31 20 566 9186, E-mail: h.koch{at}amc.uva.nl
(Received 26 July 2003; first review notified 4 September 2003; in revised form 25 November 2003; accepted 8 December 2003)
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ABSTRACT |
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INTRODUCTION |
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Once the physician suspects excessive alcohol consumption there are different methods to further confirm this possibility. First, there are several questionnaires and interviews focussing on the problems that might be caused by excessive alcohol consumption such as the Michigan Alcoholism Screening Test (MAST) (Selzer, 1971), its adaptations (Pokorny et al., 1972
; Selzer et al., 1975
; Kristenson and Trell, 1982
), the CAGE questionnaire (Ewing, 1984
) or the Alcohol Use Disorder Identification Test (AUDIT) (Saunders et al., 1993
). Second, there are methods with diaries focussing on the quantification of alcohol consumption, for example quantityfrequency, time-period or time-line follow-back methods (Sobell et al., 1988
; Webb et al., 1990
). The difficulty with these specific questionnaires and quantification diaries is that in general people who drink alcohol tend to neglect or underestimate their alcohol consumption (Popham and Schmidt, 1981
; Watson et al., 1984
). Therefore, more objective laboratory markers are often used, such as gamma-glutamyl-transferase (GGT) or mean corpuscular volume (MCV). However, applying the usual cut-off points for these tests, GGT turns out to have a low specificity whereas MCV shows a low sensitivity (Chick et al., 1981
; Eckardt et al., 1981
; Yersin et al., 1995
). This may lead to unnecessary further testing or a gross misunderstanding with the patient.
Approximately 20 years ago another laboratory parameter, carbohydrate deficient transferrin (CDT), became available. This marker is a desialylated transferrin variant appearing in serum. It measures the accumulated effect of alcohol con-sumption, appearing after regular intake of 6080 g of ethanol per day (approximately 710 units per day) for at least 1 week and normalizes slowly during abstinence (half-life = about 15 days) (Stibler, 1991). At its introduction, this test was supposed to be more specific and more sensitive than the former blood tests in the early studies (Stibler et al., 1978
, 1979
, 1980
, 1986
).
When a new test becomes available, it is often first studied in case-control studies, comparing the results in known cases (e.g. known alcoholics) with these in healthy controls (in many studies concerning CDT even teetotallers) (Lijmer et al., 2001). When promising results are found, the new test is subsequently evaluated in prospective studies, in which the new test is often first tested in selected samples and only later on in a broader spectrum of participants within different health care settings. Differences in design and patient characteristics influence test parameters like sensitivity, specificity and likelihood ratios (Lijmer et al., 1999
). The final step in evaluating a new test is a thorough systematic review of the test performance in different circumstances and studies. Such a summary provides an estimate of the overall accuracy of the test in question, or, in case of heterogeneity, identifies relevant subgroups and their respective test parameters.
Others have already reviewed the CDT test in a narrative way (Stibler, 1991; Allen et al., 1994
), sometimes in combination with a review of other laboratory markers (Rosman, 1992
; Mihas and Tavassoli, 1992
; Goldberg and Kapur, 1994
; Potter, 1994
; Yersin et al., 1995
; Conigrave et al., 1995
; Litten et al., 1995
; Sillanaukee, 1996
; Lesch and Walter, 1996
; Allen et al., 1998
; Rosalki, 1999
). Recently, Salaspuro and Scouller used a more systematic approach (Salaspuro, 1999
; Scouller et al., 2000
). However, these reviews closed inclusion of studies at 1998 and Salaspuro did not assess the methodological quality of the included studies, which recently showed to be of utmost importance by Lijmer et al., who showed that methodological shortcomings lead to substantial overestimation of test parameters (Lijmer et al., 1999
). Most of the available reviews concluded CDT being a more accurate laboratory marker for excessive alcohol consumption, more specific than GGT and more sensitive than MCV.
Because this conclusion may be of great importance for various health care fields we decided to conduct a state-of-the-art systematic review applying to the most recent methodological guidelines for conducting one, in order to reach a valid and applicable conclusion on the diagnostic accuracy of CDT in the detection of excessive alcohol consumption.
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MATERIALS AND METHODS |
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Search strategy
To identify articles on the subject a computerised search was performed, using MEDLINE (01/196606/2003), EMBASE (01/198806/2003) and Current Contents (04/199806/2003). We used the text words CDT, carbohydrate deficient transferrin and alcohol and subject headings regarding excessive alcohol consumption (drinking behaviour, alcohol-related disorders and alcoholic intoxication). The search was supplemented by reference checking. The complete search strategy is available upon request from the corresponding author.
Selection
We aimed to include articles that reported on CDT levels compared with a reference standard consisting of self-reported alcohol consumption (convertible in grams of alcohol per day). This reference standard [the goldness (validity) of which is, of course, open to discussion] is often used in alcohol research. A more suitable and in comparative research widely used reference standard is to our opinion not available at present. Articles had to concern the detection of excessive alcohol consumption. As our aim was to evaluate the test in a general medical population, articles were excluded when they concerned treatment or relapse detection of excessive alcohol consumption and when handling traffic offenders. All retrieved references were first assessed on eligibility on basis of their titles, abstracts and keywords by two of the authors (H.K. and W.J.J.A.). A full text copy was retrieved when either presumed eligible or unclear and the same authors decided on final inclusion. Only articles written in languages mastered by all reviewers (English, German and Dutch) were included (Moher et al., 2000). Initial agreement, expressed as percentage and kappa, was computed for both steps of the inclusion (Brennan and Silman, 1992
).
Quality assessment
Quality assessment of the included primary studies was done by two of the other authors (J.O.M.Z. and G.J.M.), with an adaptation of the quality assessment list for diagnostic studies of the Cochrane Methods Group on Systematic Reviews of Screening and Diagnostic Tests (Cochrane Working Group on Systematic Review of Screening and Diagnostic Tests, 1996). The used quality items are summarized in Table 1. The complete list is available upon request from the corresponding author. Special attention was paid to the subset of criteria, for which it has been proven that violation leads to overestimation of the accuracy of a diagnostic test (Lijmer et al., 1999
), and to which we refer to as Lijmer criteria. Those criteria (marked * in Table 1) were: use of same reference standard (avoidance of selection and verification bias), blind interpretation of index test and reference standard results and appropriate spectrum of disease in the research population. The spectrum of disease was considered appropriate when the study concerned either consecutive patients or a selected sample of patient categories in which the components of the spectrum lie close to each other (e.g. moderate versus heavy drinkers). Spectrum of disease was called inappropriate when components of the spectrum were lying far apart from each other (e.g. known alcoholics versus teetotallers) or when the spectrum of disease was unclear.
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Data extraction
Finally, only the studies scoring positive on all of the Lijmer criteria were considered eligible for the quantitative analysis. The quantitative data-extraction was performed by two of the authors (H.K. and M.F.H.) independently, reconstructing 2 x 2 contingency tables, extracting used cut-off points for the CDT test and, when necessary, converting the cut-off points of the reference standard into grams of alcohol per day. Differences were discussed. When no consensus could be reached a third author (W.J.J.A.) made the final decision.
Statistical analysis
An adapted decision tree based on that of Midgette et al. (1993) was used to decide which kind of meta-analytic method for summarising diagnostic test performances was most appropriate (Fig. 1). This algorithm takes into account the association between the extracted sensitivities and specificities, possible heterogeneity of the studies and identification of relevant subgroups. In this method the association between the sensitivities and specificities is expressed by Spearman's rho (R in Fig.1). When hetero-/homogeneity of studies needs to be tested, this is done by means of a Fisher's exact test.
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RESULTS |
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Study characteristics
The characteristics of the 26 studies included in the analyses are listed in Table 2. Among the various studies a broad variety of test assays, cut-off points of index and reference tests, and patient populations was present. In some studies, the type of assay was unclear (Jaakkola et al., 1994; Lesch and Walter, 1996
; Lott et al., 1998
). In the remaining studies lots of different assays were evaluated (Legros et al.; Kaneko et al., 1994
; Heil et al., 1994
; Brathen et al., 2001
). Actually, only CDTect- and CDTriTIA-assays were investigated in more than two studies.
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DISCUSSION |
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Our review illustrates that in its relatively short existence the CDT test, like many other tests, progressed through the various stages of test evaluation as mentioned in the introduction. The methodological more sound studies almost exclusively were published after 1993. Remarkably, reviews as early as 1991 (Stibler, 1991; Rosman, 1992
; Mihas and Tavassoli, 1992
), already concluded that CDT was a good test for detection of problematic alcohol consumption. The two recent, more systematic reviews were more careful. Salaspuro concluded that CDT was slightly better than the conventional laboratory markers (Salaspuro, 1999
). Scouller et al. already emphasized the need for ongoing and careful assessment of the evidence and for high quality research (Scouller et al., 2000
).
Unresolved issues
This review highlights some important unresolved issues. In retrospect, the early reviews and editorials on this topic have actually been based on potentially flawed studies, as the studies applying to important validity items were only published relatively recently. We especially focussed on these methodologically more sound studies and in fact found that just few assays have been properly evaluated in more than two studies. The data on the assays that have been evaluated in multiple valid studies unfortunately do not allow a summary measure (a summary ROC curve with a sufficiently broad range of values or a pooled sensitivity/specificity). This heterogeneity brings us to the question which sensitivity or specificity can be applied for use in daily practice? Obviously, this question cannot be answered yet. We assumed that clinical heterogeneity could, at least partially, explain the statistical heterogeneity. Unfortunately, our quest for sensible subgroups revealed that most patient populations (like primary care patients, patients with vague complaints or high and low age groups) have not been evaluated in a sufficient number of studies. We also need more studies specifically on women, as there were only few of the remaining sound studies reporting on the accuracy of the CDT test in women.
Methodological considerations
We chose to analyse only those studies applying to certain core validity criteria, since Lijmer et al. empirically demonstrated the quantitative effect of these study design shortcomings on estimates of diagnostic accuracy (Lijmer et al., 1999). We wanted to get as close to the unbiased estimate of accuracy measures as possible. Applying the strict validity requirements resulted in a relatively small number of studies that still turned out to be very heterogeneous and difficult to summarize. Nevertheless, we did not want to make any concessions to these criteria.
Another interesting aspect is the choice of reference standard, in our review consisting of self-reported alcohol consumption (convertible in grams of alcohol per day). One can question the goldness of this reference standard. Theoretically, the index test can be more accurate then the reference standard. One can imagine patients denying their drinking problems, underestimating the amount of alcohol they drink per day, and therefore scoring negative on the reference standard. When their CDT level turns out to be above the cut-off value, these results would turn them from being true-positives (scoring positive on reference standard and index test) into being false-positives (scoring negative on the reference standard and positive on the index test). This shift would result in both a lower sensitivity and specificity of CDT. When subsequently the researchers keep the specificity of the index test high by increasing the cut-off point for the CDT test, this would even further lower the sensitivity, because of a shift of patients from true-positives to false-negatives. As a better reference standard is not available, we should be aware of the influence of an imperfect reference test on the found accuracy measures. Thus, perhaps the sensitivity of the CDT test is higher than we found.
Overall considerations
Much research has been done on the accuracy of CDT in detecting excessive alcohol consumption. Nevertheless, the variability of results between the high validity studies, especially the heterogeneity of sensitivity, could not be explained by presence of different subgroups or by methodological differences. Therefore, the validity of the CDT test as a diagnostic tool is still unclear, despite its already wide use and marketing. The sensitivity of the CDT tests in the lower range of the summary of values (Fig. 3) seems to be too low to be of practical clinical use. Consequently, the CDT test cannot be recommended in settings in which high test sensitivity is essential, like in unselected populations (low prevalence of the disease) or patients with unclear complaints (false-negative test results unwanted). For example, using the low sensitivity of 30% from the study of van Pelt (van Pelt et al., 2000), two out of three subjects with excessive alcohol consumption would be missed.
Recommendations
A summary of recommendations can be found in Table 4.
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Furthermore, it is desirable that new test evaluations report on a broader variety of cut-off points of CDT than the present studies, not only on the high-specific ones. Because of the sub-optimal performance of the CDTect assay it might be interesting to keep on evaluating the other assays as well for comparison.
When more of these methodological sound comparable studies are performed, firmer conclusions can be drawn concerning the accuracy of CDT in the detection of excessive alcohol consumption. Until then it is unclear whether CDT does fulfil the expectation that it combines the sensitivity of GGT and the specificity of MCV in one assay.
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