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Validation of the Test Your Memory (FTYM Test) in a French Memory Clinic Population a
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Nicolas Postel-Vinay , Olivier Hanon , Pierre Clerson , Jeremy M d
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Brown , Joël Ménard , Elena Paillaud , Eliana Alonso , Florence h
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Pasquier , Sylvie Pariel , Serge Belliard , Jean-Jacques Péré & Joel g
Belmin a
Hypertension unit, Georges Pompidou European Hospital, 75015 Paris, France
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Department of Geriatry, Broca Hospital, 75013 Paris, France
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Orgamétrie Biostatistics, 59100 Roubaix, France
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Department of Neurology, Addenbrooke’s Hospital, Cambridge CB2 2QQ, UK e
University of Paris Descartes, Sorbonne, 75006 Paris, France
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Department of Internal Medicine and Geriatry, Henri Mondor Hospital, 94410 Créteil, France g
Department of Geriatry, Charles Foix Hospital, 94200 Ivry sur Seine, France h
Salengro Hospital, 59037 Lille, France
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Hôpital Charles Foix, 94205 Ivry-sur-Seine Cedex, France
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CHU Pontchaillou – service de neurologie, 35000 Rennes, France
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Novartis, 92506 Rueil-Malmaison, France Published online: 04 Aug 2014.
To cite this article: Nicolas Postel-Vinay, Olivier Hanon, Pierre Clerson, Jeremy M Brown, Joël Ménard, Elena Paillaud, Eliana Alonso, Florence Pasquier, Sylvie Pariel, Serge Belliard, Jean-Jacques Péré & Joel Belmin (2014) Validation of the Test Your Memory (F-TYM Test) in a French Memory Clinic Population, The Clinical Neuropsychologist, 28:6, 994-1007, DOI: 10.1080/13854046.2014.934716 To link to this article: http://dx.doi.org/10.1080/13854046.2014.934716
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The Clinical Neuropsychologist, 2014 Vol. 28, No. 6, 994–1007, http://dx.doi.org/10.1080/13854046.2014.934716
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Validation of the Test Your Memory (F-TYM Test) in a French Memory Clinic Population Nicolas Postel-Vinay1, Olivier Hanon2, Pierre Clerson3, Jeremy M Brown4, Joël Ménard5, Elena Paillaud6, Eliana Alonso7, Florence Pasquier8, Sylvie Pariel9, Serge Belliard10, Jean-Jacques Péré11, and Joel Belmin7 1
Hypertension unit, Georges Pompidou European Hospital, 75015 Paris, France Department of Geriatry, Broca Hospital, 75013 Paris, France 3 Orgamétrie Biostatistics, 59100 Roubaix, France 4 Department of Neurology, Addenbrooke’s Hospital, Cambridge CB2 2QQ, UK 5 University of Paris Descartes, Sorbonne, 75006 Paris, France 6 Department of Internal Medicine and Geriatry, Henri Mondor Hospital, 94410 Créteil, France 7 Department of Geriatry, Charles Foix Hospital, 94200 Ivry sur Seine, France 8 Salengro Hospital, 59037 Lille, France 9 Hôpital Charles Foix, 94205 Ivry-sur-Seine Cedex, France 10 CHU Pontchaillou – service de neurologie, 35000 Rennes, France 11 Novartis, 92506 Rueil-Malmaison, France 2
The Test Your Memory (TYM) test has been proposed for screening dementia. We present a French version and its validation in memory clinics. F-TYM was administered to 201 patients with memory complaints visiting five secondary referral hospital centers. Final diagnosis was dementia in 34%, amnestic mild cognitive impairment (MCI) in 32%, non-amnestic MCI in 11%, absence of cognitive disorder in 23% and F-TYM scores were respectively (M ± SD) 30.9 ± 7.6, 40.5 ± 6.3, 44.3 ± 4.5 and 43.5 ± 6.6 (p < .0001). F-TYM showed high correlation with MMSE (r = .78), excellent internal consistency, no effect of educational level, sex, or mood but a significant effect of age (p = .004). A F-TYM score ≤ 39 had 0.90 sensitivity and 0.70 specificity for diagnosis of dementia. F-TYM was unable to discriminate MCI and patients without cognitive disorders. F-TYM could be proposed for screening of dementia in patients with memory complaints. Keywords: Dementia; Alzheimer’s disease; Mild Cognitive Impairment; General practice; Test Your Memory Test; TYM.
INTRODUCTION An estimated 24 million people worldwide suffer from dementia. The prevalence is expected to double every 20 years as the population ages (Ferri et al., 2005). The importance of early recognition of dementia and the crucial role of primary care physicians have recently been emphasized (National Institute for Health and Clinical Excellence/Social Care Institute of Excellence, 2006). Currently there is a long delay between symptom onset and diagnosis, varying from 8 to 32 months (Bond, Stave,
Address correspondence to: Nicolas Postel-Vinay, Georges Pompidou European Hospital, Hypertension unit, 75015 Paris, France. E-mail: [email protected] (Received 16 June 2013; accepted 10 June 2014)
© 2014 Taylor & Francis
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Sganga, O’Connell, & Stanley, 2005; Wilkinson, Stave, Keohane, & Vincenzino, 2004). This “diagnosis gap” (Menon & Larner, 2011) delays access to social support and may increase the patient’s and carer’s anxiety. Primary care physicians have only 10–15 minutes (Deveugele, Derese, Van den Brink-Muenen, Bensing, & De Maeseneer, 2002) to evaluate patients with cognitive problems. There is a need for cognitive tests which examine many domains and take a minimum of medical time. A total of 53 brief screening instruments have been identified by the US Preventive Services Task Force (Lin, O’Connor, Rossom, Perdue, & Eckstrom, 2013). Of these, 29 claimed to be administered in less than 5 minutes. However, only 12 brief instruments have been studied more than once in well-designed studies that evaluated their ability to detect dementia in primary-care-relevant populations. These tests support the diagnosis of dementia but diagnosis of dementia remains a clinical one (Villarejo & Puertas-Martin, 2011). The Mini-Mental State Examination (MMSE) (Folstein, Folstein, & McHugh, 1975) is the best-studied instrument and the gold standard of short cognitive tests (Tombaugh & McIntyre, 1992). The MMSE, however, lacks sensitivity to detect earliest changes of Alzheimer’s disease (AD), especially in highly educated patients (O’Bryant et al., 2008), and the 10 minutes it takes to administer is judged too long by 58% of physicians (Tangalos et al., 1996). It remains underused in primary care (Menon & Larner, 2011). Other brief cognitive tests used in screening of dementia examine only limited cognitive domains (Borson, Scanlan, Watanabe, Tu, & Lessig, 2005; Belmin et al., 2007; Buschke et al., 1999; Canning, Leach, Stuss, Ngo, & Black, 1951; Hanyu et al., 2011). The Test Your Memory (TYM) is a new short cognitive test designed to help health professionals in the screening of AD and other forms of dementia. It is not a diagnostic test and does not substitute for physician’s diagnosis. It requires little medical supervision and can be self-administered with the help of a nurse or a patient’s relative. The TYM is a series of 10 tasks on a double-sided sheet of card with spaces for the patient to fill in responses. The tasks are orientation (10 points), ability to copy a sentence (2 points), semantic knowledge (3 points), calculation (4 points), verbal fluency (4 points), similarities (4 points), naming (5 points), visuospatial abilities (7 points), and recall (6 points). The ability to do the test is also scored from 5 points for patients requiring no help to 1 point for patients requiring major help. Help is limited to encouragements and to be sure the test is performed adequately, for example by explaining the task to be done. The maximum F-TYM score is 50 points. The TYM was designed to meet three critical requirements: take minimal operator time to administer, test a reasonable range of cognitive functions, and be sensitive to mild AD (Brown, Pengas, Dawson, Brown, & Clatworthy, 2009). The TYM is not intended to replace MMSE but to offer a test when currently no test is done. In the index study (Brown et al., 2009) performances to TYM were 47/50 for control participants (n = 282) and 33/50 for patients with AD (n = 94 including 9 patients with amnestic Mild Cognitive Impairment [MCI] performing poorly on the Addenbrooke’s cognitive examination). TYM score was highly correlated with MMSE. A score ≤ 42/50 had a 93% sensitivity and a 86% specificity in the diagnosis of AD. Translations of the TYM test and several validations in foreign languages are complete (Hanyu et al., 2011; Ojeda, Salazar, Duenas, & Failde, 2011; Van Schalkwyk, Botha, & Seedat, 2012). We present here the French version of the TYM test (F-TYM, for French TYM) and its validation in memory clinics. We assessed its properties
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including sensitivity, specificity, and positive and negative likelihood ratio (LR) in dementia diagnosis in clinical practice.
METHOD
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F-TYM The TYM test was translated in accordance with international guidelines (Guillemin, Bombardier, & Beaton, 1993). Two independent French translations were obtained. Cross-cultural adaptation was needed for the sentence to be copied and this adaptation respected the author’s requirements: six words conveying information, no pronouns. The sentence must be not logical, so cannot be recalled from the first couple of words and cannot not be a well-known phrase. In the verbal fluency test, names of animals beginning with “S” were replaced by names beginning with “C” as there are more animals whose name starts with “C” than with “S” in French. After a pilot study (n = 10) cross-cultural adaptation was achieved during a consensus meeting attended by French physicians and the English author of the TYM. F-TYM was then back-translated into English. The back-translated version was found to be conceptually identical to the original version. Participants An observational, cross-sectional study was conducted between March 2011 and December 2011 in five secondary referral hospital centers in France. Patients were prospectively recruited. Consecutive ambulatory patients with memory complaints who visited a memory consultation for the first time were recruited. Exclusion criteria were inability to read or write or understand French, known dementia, and major depressive disorder. Depending on the workload of the center the study was proposed to a random sample of patients meeting inclusion criteria. A total of 213 patients were recruited, of whom 12 were excluded from analysis: in 7 a diagnosis was not made, in 4 dementia had been previously diagnosed, and 3 patients had previously visited a memory clinic. The remaining 201 patients were included. The participant characteristics are summarized in Table 1 and the recruitment process summarized in Figure 1. Procedures F-TYM was administered prior to any cognitive assessment at the clinic under supervision of a health professional. Help was limited to clarifying instructions. The supervisor was not allowed to give answers to the patient. Once completed the F-TYM was sealed in an envelope and sent to the research center, with the attending physicians unaware of the F-TYM results (Gifford & Cummings, 1999). The patient then completed usual center procedures including the MMSE (GRECO version) (Puel & Hugonot-Diener, 1996). Mood was evaluated with the 30-item Geriatric Depression Scale (GDS-30) (Yesavage et al., 1983). Centers had the choice to conduct all tests they judged necessary for the diagnosis. Diagnosis of dementia was established according to
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Table 1. Patient characteristics. N = 201
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Female Age (years) Educational status Primary education (school)
137 (68%) 76 ± 10 (41–94;79) 101 (51%)
Secondary education (college)
43 (21%)
Higher education (university)
56 (28%)
GDS-30 (/30) MMSE (/30) Anxio-depressive disorder (anxiety or minor depression) Diagnosis Dementia No dementia
9.9 ± 5.5 (0–25;9) 24.4 ± 4.7 (5–30;25) 59 (29%) 68 (34%) 133 (66%)
No cognitive disorder*
46 (23%)
MCI
87 (43%)
Non amnestic, single domain MCI
11 (5%)
Non amnestic, multiple domain MCI
11 (5%)
Amnestic, single domain MCI
16 (8%)
Amnestic, multiple domain MCI
49 (24%)
Results are expressed as mean ± standard deviation (minimum–maximum;median) for continuous variables and as number (percentage) for categorical variables. *Patients with cognitive complaints in whom no cognitive disease is diagnosed on the initial appointment. MCI: Mild Cognitive Impairment.
Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria (Wilson & Skodol, 1994). Diagnosis of MCI was established according to European Consortium criteria (Portet et al., 2006) and Petersen criteria (Petersen et al., 1999). The diagnosis was established at the end of evaluations: no cognitive disorder, non-amnestic MCI, amnestic MCI (Gauthier et al., 2006), and dementia. The F-TYM result was analyzed independently by two physicians unaware of the diagnosis. Ethics This study was conducted in compliance with the Good Clinical Practices protocol and Declaration of Helsinki principles. Usual procedures were not modified by the patient’s participation in the study. Approval of a French Ethical Board (Comité de Protection des Personnes du Groupe Hospitalier Pitié-Salpétrière) was sought and it was confirmed that the study was non-interventional. Patients gave informed consent to participate prior to any procedure.
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213 patients recruited
12 patients excluded from analysis (diagnosis not collected
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N = 7, known dementia N = 4, had already visited a memory clinic N = 3)
201 patients analyzed
No
Dementia
Amnestic MCI
Other form of
cognitive
N = 68
N = 65
MCI
disease
N = 22
N = 46
Figure 1. Flow diagram according to diagnosis on initial appointment. No cognitive disease = patients with cognitive complaints in whom no cognitive disease is diagnosed on the initial appointment.
Statistics The main objective of the study was to assess sensitivity and specificity of F-TYM in the diagnosis of dementia. Positive and negative LR were calculated. Based on Bayes’ theorem, LR allows calculation of the probability of dementia for a patient based on the test results and the pre-test probability of dementia (estimated to be equal to prevalence in the studied population). Post-test probability was derived from pre-test odds by multiplying odds by LR. Cut-offs for the diagnosis of dementia using the F-TYM score were calculated by logistic regression and plot of a receiver operating characteristics (ROC) curve for patients with dementia compared to those with MCI or no cognitive disorders. Since amnestic disorders and dementia are on a spectrum without a clear dividing line, a further analysis was conducted excluding patients with MCI whether amnestic or not. Internal consistency was assessed with the Cronbach’s α coefficient (Cronbach, 1951), concurrent validity was assessed against MMSE and GDS-30 with Pearson correlation coefficients. Inter-rater reliability was evaluated with the intra-class correlation
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coefficient (Shrout & Fleiss, 1979). F-TYM results were compared between patients with depressed mood (GDS-30>22) and other patients using analysis of variance. F-TYM results were compared according to the final diagnosis using analysis of variance followed by post-hoc tests (Bonferroni method dealing with type I error rate inflation associated with multiple comparisons). Sample size was estimated according to the method proposed by Simel and Samsa (1991) using the following parameters: 50% of patients visiting the memory clinic would be diagnosed with dementia; sensitivity and specificity would be respectively 0.93 and 0.86 (i.e., a positive LR of 6.64 and a negative LR of 0.08; Brown et al., 2009); 194 patients were required to estimate a positive LR of 6.68 with a confidence interval (CI) of 3.3–13.3. For a 50% pre-test probability of dementia and knowing the positive results of F-TYM, the post-test probability of dementia would be included within the range 0.77–0.93. Statistical analysis was conducted with SAS 9.1 software (SAS Institute, Cary, North Carolina, USA).
RESULTS F-TYM administration F-TYM was well accepted by patients and required minimal supervision. A total of 85 patients (43%) did not require any help, 89 (44%) required minor help, 19 (10%) needed moderate help, and only 7 (3%) required major help. Mean help score was 3.5 ± 1.3/5 (mean ± SD/maximal theoretical score). Patients aged over 80 years, those with lower education level, and those with dementia required more help (p = .01, p = .02 and p = .01 respectively). F-TYM score The mean F-TYM total score was 38.4 ± 8.6. The score was not normally distributed (Kolmogorov-Smirnov test, p < .01) with a ceiling effect. Scores were lower in older patients (p < .0001) even in patients without cognitive disorders (p = .004). F-TYM score was lower in poorly educated patients compared to the whole population (p < .0001). However, when examining only patients without cognitive disorders, there was no influence of educational level after adjustment on age (p = .34). F-TYM validation Cronbach α was 0.83 showing excellent internal consistency. F-TYM score was highly correlated with MMSE (Pearson’s correlation coefficient r = .78, p < .0001). There was no correlation between F-TYM score and GDS-30 (r = –.03, p = .66) indicating that the F-TYM test was not influenced by mood in these patients with no known major depressive episode. Inter-rater agreement was excellent; intraclass correlation coefficient = 0.99; 95% CI (0.987–0.992).
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Utility of F-TYM for screening of dementia and MCI
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F-TYM score was 43.5 ± 6.6 in patients without organic disorders, 44.3 ± 4.5 in patients with non-amnestic MCI, 40.5 ± 6.3 in patients with amnestic MCI, and 30.9 ± 7.6 in patients with dementia (p < .0001). Similar results were found after adjustment on age, sex, and educational level. There was no difference in the overall F-TYM score between amnestic MCI patients, non-amnestic MCI patients and patients without cognitive disorder (Table 2).
Table 2. F-TYM score. F-TYM score All patients (N = 201)
38.35 ± 8.61
Influence of sex Male (N = 64)
38.05 ± 9.24
Female (N = 137) Influence of age < 70 years old (N = 51)
0.73
38.50 ± 8.33
41.63 ± 8.30
70-80 years old (N = 59)
40.27 ± 8.53
≥80 years old (N = 91)
35.27 ± 7.84
Influence of education Primary education (N = 101)
p value
< .0001
35.93 ± 7.94
Secondary education (N = 43)
38.88 ± 8.09
Higher education (N = 56)
42.29 ± 8.99
GDS-30 < 15 (N = 143)
37.94 ± 8.79
15-22 (N = 34)
38.56 ± 8.42
> 22 (N = 4)
41.75 ± 7.32
Diagnosis No cognitive disorder (N = 46)
43.46 ± 6.62
Non amnestic MCI (N = 22)
44.27 ± 4.50
Amnestic MCI (N = 65)
40.51 ± 6.35
Dementia (N = 68)
30.93 ± 7.56
< .0001
0.69
< .0001*
Results are expressed as mean ± standard deviation; *differences are significant between dementia and each other diagnosis (Bonferroni post hoc test). MCI: Mild Cognitive Impairment.
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Considering each subscore separately, all but the ability to copy a sentence were significantly lower in patients with dementia compared to patients without cognitive disorder (p < .0001). Patients with non-amnestic MCI scored similarly to patients without cognitive disorder for each subscore. Patients with amnestic MCI scored lower than patients with no cognitive disorders or non-amnestic MCI on recall. A F-TYM score ≤ 39 had 0.90 sensitivity and 0.70 specificity regarding the diagnosis of dementia (area under the curve 0.88 95% CI, 0.83–0.92; Figure 2). Positive LR was 2.98 (95% CI, 1.59–5.59), negative LR was 0.15 (0.07–0.31) compared to all other patients—including those with MCI. Among 101 patients with F-TYM score ≤ 39, 61 (60.4%) were diagnosed with dementia. In 100 patients with F-TYM score > 39, 7 (7.0%) were diagnosed with dementia. Therefore the false positive rate was 39.6% and the false negative rate was 7.0%. A further analysis was conducted assessing the F-TYM properties to distinguish patients with dementia from those with no cognitive diagnosis. A F-TYM score ≤ 40 had 0.93 sensitivity and 0.76 specificity regarding the diagnosis of dementia (area under the curve 0.90. 95%, CI 0.88–0.96; Figure 3). The optimal cut-off value of MMSE for diagnosis of dementia in the studied population was 24 (sensitivity 0.88, specificity 0.83, positive LR 5.29 [2.11–13.25], negative LR 0.14 [0.08–0.28]). Properties of F-TYM and MMSE are summarized in Table 3.
DISCUSSION F-TYM Despite minor cross-cultural adjustments, the F-TYM has demonstrated the same properties as the English TYM. F-TYM was well accepted by patients, administration 1 0.9 0.8 0.7
Sensitivity
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0.6 0.5 0.4 0.3 Area under the curve (AUC) = 0.88
0.2 0.1 0 0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
1-specificity
Figure 2. ROC curve assessing F-TYM properties for dementia screening among patients with memory complaints.
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Sensitivity
0.7 0.6 0.5 0.4 0.3 Area under the curve (AUC) = 0.90
0.2 0.1 0 0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
1-specificity
Figure 3. ROC curve assessing F-TYM properties for dementia screening in a population excluding MCI patients. Flow diagram according to diagnosis on initial appointment No cognitive disease=patients with cognitive complaints in whom no cognitive disease is diagnosed on the initial appointment.
Table 3. Metrological properties of F-TYM and MMSE. F-TYM ≤ 39 Sensitivity Specificity Youden index Positive likelihood ratio Negative likelihood ratio Positive predictive value Negative predictive value Area under ROC curve
0.90 0.70 0.60 2.98 (1.59–5.59) 0.15 (0.07–0.31) 0.60 0.93 0.88
MMSE ≤ 24 0.88 0.83 0.71 5.29 (2.11–13.25) 0.14 (0.07–0.28) 0.73 0.93 0.92
was easy and required little help. Patients with dementia required more help than normal patients or patients with MCI. Internal consistency and inter-rater reliability were excellent as previously reported (Brown et al., 2009; Hanyu et al., 2011). All the subtest scores except copying were significantly impaired in patients with dementia. Our study addressed some important issues: 1. F-TYM was found to be well correlated with MMSE , it was much less timeconsuming for the physician. Internal consistency and inter-rater reliability were excellent as previously reported (Brown et al., 2009; Hanyu et al., 2011). 2. There was no effect of sex, education, and depressed mood on F-TYM results, but a significant effect of age even in patients without cognitive disorders. The absence of educational effects in patients without cognitive disorder is probably because the F-TYM is quite an easy test so there is a ceiling effect. Older
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4.
5. 6.
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patients scored lower than younger ones raising interest in setting-up cut-offs based on patients’ age for clinical practice. As there was no effect of education on the F-TYM scores then no educational correction was necessary. In countries with a lower standard of general education such a correction might be needed. Global score and subset scores except copying were significantly impaired in patients with dementia F-TYM discriminated patients with dementia from those with MCI or no cognitive disorder. The optimal cut-off score was 39 and was associated with a 0.90 sensitivity and a 0.70 specificity. F-TYM did not distinguish amnestic MCI patients from those with no cognitive diagnosis on the overall score, but did so on the recall score. F-TYM did not distinguish non-amnestic MCI patients from those without cognitive disorder, but the sample was small. F-TYM for screening dementia in participants with memory complaints
Our study did not reproduce the results of the index study (Brown et al., 2009). Mean F-TYM was 31 ± 8 in patients with dementia and 43 ± 6 in normal patients, while it was 33 and 47 respectively in the index study. We found that the optimal cutoff for screening dementia was 39 with a 90% sensitivity and a 70% specificity, a lower value than the cut-off of 42 proposed in the index study (sensitivity 93%, specificity 86%). Such differences could be due to (1) differences in methods, (2) differences in the definition of dementia, and (3) differences in severity of dementia. First, the index study was a case-control study in which cases and controls were age-matched and controls were patient’s relatives with no history of neurological disease, memory problems, or brain injury. Our study was conducted in in memory clinics with patients with memory complaints; thus, our “control” patients were patients with memory complaints in whom no cognitive disorder was diagnosed after extensive assessment. Recruitment of patients with AD and normal controls partially explains an over-estimation of specificity when compared to a cohort in which all patients had memory complaints. In a study conducted on consecutive patients in two memory clinics, the authors (Hancock & Larner, 2011) found an optimal cut-off of 30 with high positive LR (6.28) but low sensitivity (73%). Second, in the index study patients with amnestic MCI and poor results on the Addenbrooke’s cognitive examination were considered as patients with early AD (Morris et al., 2001) which led to a higher cut-off. Our data did not allow us to make such a distinction among amnestic MCI patients. Considering amnestic MCI patients as non-demented patients, Hancock and Larner likewise found a markedly lower optimal cut-off. Finally, severity of dementia plays a major role in the cut-off determination. In the Hancock and Larner study, mean MMSE showed that demented patients were more severely impaired than in our study. The more impaired the demented patients, the lower the expected cut-off. F-TYM for screening MCI in participants with memory complaints AD is a progressive disease. Some but not all MCI may be considered as prodromal stages of AD. Current treatments do not cure or alter the progressive course
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of dementia (Lorentz, Scanlan, & Borson, 2002) but other measures (such as treatment of comorbid conditions, initiation of psychosocial support) may be useful at early symptomatic stages. The F-TYM was not found appropriate to detect MCI and its different variants, which is also true for the MMSE (Villarejo & Puertas-Martin, 2011). This has also been recognized with the index version (Brown et al., 2009). Patterns of scores may be more useful than the overall score for diagnosing amnestic MCI. Indeed we found that patients with amnestic MCI performed as patients without cognitive disorders on all subtests except sentence recall. In the validation process of the Japanese version of TYM, the authors (Hanyu et al., 2011) found that a cut-off score of 44/50 may discriminate patients with MCI from patients with no cognitive disorder because they performed significantly worse on orientation, semantic knowledge, anterograde memory, and executive function. Their validation study, however, was not conducted in usual clinical setting conditions but reproduced methods of the index study.
F-TYM in clinical practice Patients referred in the participating centers are not representative of the general population. In our study final diagnosis was dementia in 34% of patients, amnestic MCI in 32%, non-amnestic MCI in 11%, and absence of cognitive disorder in 23%. Numbers would be quite different in a primary care setting with a lower frequency of dementia. The high frequency of dementia produced more precise estimations of LR. The post-test probabilities (i.e., proportion of patients with dementia in patients with F-TYM ≤ 39) can be calculated by multiplying pre-test odds by positive LR. For example, assuming a prevalence of 10% of dementia, the probability for a patient to be diagnosed with dementia knowing the TYM-test score is ≤ 39, is 0.25. Slightly better results are expected with MMSE ≤ 24 which appeared to be the optimal cut-off value in our study giving an expected post-test probability of 36%. It should be remembered that we have considered MCI patients as not demented. Today no single tool is recognized as the “gold standard” for detection of cognitive impairment in primary care. Numerous tools apart from MMSE have been proposed. Among them General Practitioner Assessment of Cognition (GPCOG), MiniCog and Memory Impairment Screen (MIS) appeared to be most suited for primary care (Brodaty, Low, Gibson, & Burns, 2006; Ismail, Rajji, & Shulman, 2010; Lorentz et al., 2002; Milne, Culverwell, Guss, Tuppen, & Whelton, 2008). They require only a little time to be administered and have little or no educational bias. Nevertheless they have some limitations. GPCOG requires an informant score to assess as pass or fail; MIS does not test executive functions or visuospatial skills. Mini-Cog and MIS are copyrighted but the owners allow free use by clinicians. All these tests are administered by the physician. By contrast F-TYM is free of charge, requires only little if any medical supervision, and explores 10 domains of cognitive function. The TYM has clear advantages over the MMSE testing a wider range of cognitive skills more thoroughly than the MMSE. In most validations (e.g., Brown et al., 2009; Hanyu et al., 2011) it has performed far better than the MMSE. In addition because it is filled in by the patient under minimal supervision it can be administered in a busy clinic with little disruption in a very short time. The Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005)
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has a similar level of difficulty to the TYM and is gaining popularity but like the MMSE takes several minutes of dedicated time to administer.
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Perspectives F-TYM appears to be an easy to use and user-friendly tool that numerous primary care physicians and nurses may find appropriate for a daily use. Hancock recommends using relatives of patients to administer the test and save medical time (Hancock & Larner, 2011). Scoring is fairly easy and instructions and scoring sheets are available from the websites tymtest.com and self-measurement.com. The F-TYM test is neither a diagnostic tool for dementia nor a substitute for a clinical assessment. It is intended to be used to actively screen patients with dementia among patients complaining of memory loss. F-TYM is a way to examine cognitive function in a formal way. The F-TYM score can aid the decision on whether to refer a patient to a memory clinic. Choice of cut-off must be driven by the needs of the particular clinical situations. Identifying as many cases as possible is associated with a higher false positive rate; inversely aiming at restricting the number of false positive means accepting to diagnose fewer cases. The main objective should be the diagnosis of early cognitive impairments, an objective that would be more important once there are effective treatments for AD. Currently diagnosis of dementia is important in the medical and social management of patients. We recommend three grades of risk: very low risk of dementia (F-TYM > 42), slight risk of dementia (39< F-TYM≤42), and high risk of dementia (F-TYM≤39). These limits are highly sensitive to the study conditions (population, age, prevalence of dementia, severity of cognitive impairment in demented patients). In all cases the final diagnosis of dementia must be made on a clinical basis by trained physicians. Consequences of a wide use of the F-TYM by primary care physicians need further evaluation.
ACKNOWLEDGMENT Novartis gave an unrestricted grant for the conduct of the study. The authors thank the patients who kindly participated in this study and the investigators who have contributed to the conduct of this study.
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Nasreddine, Z. S., Phillips, N. A., Bedirian, V., Charbonneau, S., Whitehead, V., Collin, I., … Chertkow, H. (2005). The Montreal Cognitive Assessment MoCA: A brief screening tool for Mild Cognitive Impairment. Journal of the American Geriatrics Society, 53, 695–699. National Institute of Health and Clinical Excellence. (2006). Dementia: Supporting people with dementia and their carers in health and social care. NICE clinical guidance 42. London: National Institute for Health and Clinical Excellence. O’Bryant, S. E., Humphreys, J. D., Smith, G. E., Ivnik, R. J., Graff-Radford, N. R., Petersen, R. C., & Lucas, J. A. (2008). Detecting dementia with the mini-mental state examination in highly educated individuals. Archives of Neurology, 65, 963–967. Ojeda, B., Salazar, A., Duenas, M., & Failde, I. (2011). Translation and adjustment into Spanish language of the screening tool for mild cognitive impairment. Medicina Clinica, 138, 429–434. Petersen, R. C., Smith, G. E., Waring, S. C., Ivnik, R. J., Tangalos, E. G., & Kokmen, E. (1999). Mild cognitive impairment: Clinical characterization and outcome. Archives of Neurology, 56, 303–308. Portet, F., Ousset, P. J., Visser, P. J., Frisoni, G. B., Nobili, F., Scheltens, P., … MCI Working Group of the European Consortium on Alzheimer’s Disease (EADC). (2006). Mild cognitive impairment (MCI) in medical practice: A critical review of the concept and new diagnostic procedure. Report of the MCI Working Group of the European Consortium on Alzheimer’s Disease. Journal of Neurology, Neurosurgery, and Psychiatry, 77, 714–718. Puel, M., & Hugonot-Diener, L. (1996). Presentation by the GRECO group of the French adaptation of a cognitive assessment scale used in Alzheimer type dementia. Presse Medicale, 25, 1028–1032. Shrout, P., & Fleiss, J. L. (1997). Intraclass correlations: uses in assessing raters’ reliability. Psychological Bulletin, 86, 420–428. Simel, D. L., Samsa, G. P., & Matchar, D. B. (1991). Likelihood ratios with confidence: Sample size estimation for diagnostic test studies. Journal of Clinical Epidemiology, 44, 763–770. Tangalos, E. G., Smith, G. E., Ivnik, R. J., Petersen, R. C., Kokmen, E., Kurland, L. T., … Parisi, J. E. (1996). The Mini-Mental State Examination in general medical practice: Clinical utility and acceptance. Mayo Clinic Proceedings, 71, 829–837. Tombaugh, T. N., & McIntyre, N. J. (1992). The mini-mental state examination: A comprehensive review. Journal of the American Geriatrics Society, 40, 922–935. Van Schalkwyk, G., Botha, H., & Seedat, S. (2012). Comparison of 2 dementia screeners, the Test Your Memory Test and the Mini-Mental State Examination, in a primary care setting. Journal of Geriatric Psychiatry and Neurology, 25, 85–88. Villarejo, A., & Puertas-Martin, V. (2011). Usefulness of short tests in dementia screening. Neurologia, 26, 425–433. Wilkinson, D., Stave, C., Keohane, D., & Vincenzino, O. (2004). The role of general practitioners in the diagnosis and treatment of Alzheimer’s disease: A multinational survey. The Journal of International Medical Research, 32, 149–159. Wilson, H. S., & Skodol, A. (1994). Special report: DSM-IV: Overview and examination of major changes. Archives of Psychiatric Nursing, 8, 340–347. Yesavage, J., Brink, T. L., Rose, T. L., Lum, O., Huang, V., Adey, M., & Leirer, V. O. (1983). Development and validation of a geriatric depression screening scale: A preliminary report. Journal of Psychiatric Research, 17, 37–49.
The Clinical Neuropsychologist Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/ntcn20
Validation of the Test Your Memory (FTYM Test) in a French Memory Clinic Population a
b
c
Nicolas Postel-Vinay , Olivier Hanon , Pierre Clerson , Jeremy M d
e
f
g
Brown , Joël Ménard , Elena Paillaud , Eliana Alonso , Florence h
i
j
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Pasquier , Sylvie Pariel , Serge Belliard , Jean-Jacques Péré & Joel g
Belmin a
Hypertension unit, Georges Pompidou European Hospital, 75015 Paris, France
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b
Department of Geriatry, Broca Hospital, 75013 Paris, France
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Orgamétrie Biostatistics, 59100 Roubaix, France
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Department of Neurology, Addenbrooke’s Hospital, Cambridge CB2 2QQ, UK e
University of Paris Descartes, Sorbonne, 75006 Paris, France
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Department of Internal Medicine and Geriatry, Henri Mondor Hospital, 94410 Créteil, France g
Department of Geriatry, Charles Foix Hospital, 94200 Ivry sur Seine, France h
Salengro Hospital, 59037 Lille, France
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Hôpital Charles Foix, 94205 Ivry-sur-Seine Cedex, France
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CHU Pontchaillou – service de neurologie, 35000 Rennes, France
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Novartis, 92506 Rueil-Malmaison, France Published online: 04 Aug 2014.
To cite this article: Nicolas Postel-Vinay, Olivier Hanon, Pierre Clerson, Jeremy M Brown, Joël Ménard, Elena Paillaud, Eliana Alonso, Florence Pasquier, Sylvie Pariel, Serge Belliard, Jean-Jacques Péré & Joel Belmin (2014) Validation of the Test Your Memory (F-TYM Test) in a French Memory Clinic Population, The Clinical Neuropsychologist, 28:6, 994-1007, DOI: 10.1080/13854046.2014.934716 To link to this article: http://dx.doi.org/10.1080/13854046.2014.934716
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The Clinical Neuropsychologist, 2014 Vol. 28, No. 6, 994–1007, http://dx.doi.org/10.1080/13854046.2014.934716
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Validation of the Test Your Memory (F-TYM Test) in a French Memory Clinic Population Nicolas Postel-Vinay1, Olivier Hanon2, Pierre Clerson3, Jeremy M Brown4, Joël Ménard5, Elena Paillaud6, Eliana Alonso7, Florence Pasquier8, Sylvie Pariel9, Serge Belliard10, Jean-Jacques Péré11, and Joel Belmin7 1
Hypertension unit, Georges Pompidou European Hospital, 75015 Paris, France Department of Geriatry, Broca Hospital, 75013 Paris, France 3 Orgamétrie Biostatistics, 59100 Roubaix, France 4 Department of Neurology, Addenbrooke’s Hospital, Cambridge CB2 2QQ, UK 5 University of Paris Descartes, Sorbonne, 75006 Paris, France 6 Department of Internal Medicine and Geriatry, Henri Mondor Hospital, 94410 Créteil, France 7 Department of Geriatry, Charles Foix Hospital, 94200 Ivry sur Seine, France 8 Salengro Hospital, 59037 Lille, France 9 Hôpital Charles Foix, 94205 Ivry-sur-Seine Cedex, France 10 CHU Pontchaillou – service de neurologie, 35000 Rennes, France 11 Novartis, 92506 Rueil-Malmaison, France 2
The Test Your Memory (TYM) test has been proposed for screening dementia. We present a French version and its validation in memory clinics. F-TYM was administered to 201 patients with memory complaints visiting five secondary referral hospital centers. Final diagnosis was dementia in 34%, amnestic mild cognitive impairment (MCI) in 32%, non-amnestic MCI in 11%, absence of cognitive disorder in 23% and F-TYM scores were respectively (M ± SD) 30.9 ± 7.6, 40.5 ± 6.3, 44.3 ± 4.5 and 43.5 ± 6.6 (p < .0001). F-TYM showed high correlation with MMSE (r = .78), excellent internal consistency, no effect of educational level, sex, or mood but a significant effect of age (p = .004). A F-TYM score ≤ 39 had 0.90 sensitivity and 0.70 specificity for diagnosis of dementia. F-TYM was unable to discriminate MCI and patients without cognitive disorders. F-TYM could be proposed for screening of dementia in patients with memory complaints. Keywords: Dementia; Alzheimer’s disease; Mild Cognitive Impairment; General practice; Test Your Memory Test; TYM.
INTRODUCTION An estimated 24 million people worldwide suffer from dementia. The prevalence is expected to double every 20 years as the population ages (Ferri et al., 2005). The importance of early recognition of dementia and the crucial role of primary care physicians have recently been emphasized (National Institute for Health and Clinical Excellence/Social Care Institute of Excellence, 2006). Currently there is a long delay between symptom onset and diagnosis, varying from 8 to 32 months (Bond, Stave,
Address correspondence to: Nicolas Postel-Vinay, Georges Pompidou European Hospital, Hypertension unit, 75015 Paris, France. E-mail: [email protected] (Received 16 June 2013; accepted 10 June 2014)
© 2014 Taylor & Francis
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Sganga, O’Connell, & Stanley, 2005; Wilkinson, Stave, Keohane, & Vincenzino, 2004). This “diagnosis gap” (Menon & Larner, 2011) delays access to social support and may increase the patient’s and carer’s anxiety. Primary care physicians have only 10–15 minutes (Deveugele, Derese, Van den Brink-Muenen, Bensing, & De Maeseneer, 2002) to evaluate patients with cognitive problems. There is a need for cognitive tests which examine many domains and take a minimum of medical time. A total of 53 brief screening instruments have been identified by the US Preventive Services Task Force (Lin, O’Connor, Rossom, Perdue, & Eckstrom, 2013). Of these, 29 claimed to be administered in less than 5 minutes. However, only 12 brief instruments have been studied more than once in well-designed studies that evaluated their ability to detect dementia in primary-care-relevant populations. These tests support the diagnosis of dementia but diagnosis of dementia remains a clinical one (Villarejo & Puertas-Martin, 2011). The Mini-Mental State Examination (MMSE) (Folstein, Folstein, & McHugh, 1975) is the best-studied instrument and the gold standard of short cognitive tests (Tombaugh & McIntyre, 1992). The MMSE, however, lacks sensitivity to detect earliest changes of Alzheimer’s disease (AD), especially in highly educated patients (O’Bryant et al., 2008), and the 10 minutes it takes to administer is judged too long by 58% of physicians (Tangalos et al., 1996). It remains underused in primary care (Menon & Larner, 2011). Other brief cognitive tests used in screening of dementia examine only limited cognitive domains (Borson, Scanlan, Watanabe, Tu, & Lessig, 2005; Belmin et al., 2007; Buschke et al., 1999; Canning, Leach, Stuss, Ngo, & Black, 1951; Hanyu et al., 2011). The Test Your Memory (TYM) is a new short cognitive test designed to help health professionals in the screening of AD and other forms of dementia. It is not a diagnostic test and does not substitute for physician’s diagnosis. It requires little medical supervision and can be self-administered with the help of a nurse or a patient’s relative. The TYM is a series of 10 tasks on a double-sided sheet of card with spaces for the patient to fill in responses. The tasks are orientation (10 points), ability to copy a sentence (2 points), semantic knowledge (3 points), calculation (4 points), verbal fluency (4 points), similarities (4 points), naming (5 points), visuospatial abilities (7 points), and recall (6 points). The ability to do the test is also scored from 5 points for patients requiring no help to 1 point for patients requiring major help. Help is limited to encouragements and to be sure the test is performed adequately, for example by explaining the task to be done. The maximum F-TYM score is 50 points. The TYM was designed to meet three critical requirements: take minimal operator time to administer, test a reasonable range of cognitive functions, and be sensitive to mild AD (Brown, Pengas, Dawson, Brown, & Clatworthy, 2009). The TYM is not intended to replace MMSE but to offer a test when currently no test is done. In the index study (Brown et al., 2009) performances to TYM were 47/50 for control participants (n = 282) and 33/50 for patients with AD (n = 94 including 9 patients with amnestic Mild Cognitive Impairment [MCI] performing poorly on the Addenbrooke’s cognitive examination). TYM score was highly correlated with MMSE. A score ≤ 42/50 had a 93% sensitivity and a 86% specificity in the diagnosis of AD. Translations of the TYM test and several validations in foreign languages are complete (Hanyu et al., 2011; Ojeda, Salazar, Duenas, & Failde, 2011; Van Schalkwyk, Botha, & Seedat, 2012). We present here the French version of the TYM test (F-TYM, for French TYM) and its validation in memory clinics. We assessed its properties
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including sensitivity, specificity, and positive and negative likelihood ratio (LR) in dementia diagnosis in clinical practice.
METHOD
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F-TYM The TYM test was translated in accordance with international guidelines (Guillemin, Bombardier, & Beaton, 1993). Two independent French translations were obtained. Cross-cultural adaptation was needed for the sentence to be copied and this adaptation respected the author’s requirements: six words conveying information, no pronouns. The sentence must be not logical, so cannot be recalled from the first couple of words and cannot not be a well-known phrase. In the verbal fluency test, names of animals beginning with “S” were replaced by names beginning with “C” as there are more animals whose name starts with “C” than with “S” in French. After a pilot study (n = 10) cross-cultural adaptation was achieved during a consensus meeting attended by French physicians and the English author of the TYM. F-TYM was then back-translated into English. The back-translated version was found to be conceptually identical to the original version. Participants An observational, cross-sectional study was conducted between March 2011 and December 2011 in five secondary referral hospital centers in France. Patients were prospectively recruited. Consecutive ambulatory patients with memory complaints who visited a memory consultation for the first time were recruited. Exclusion criteria were inability to read or write or understand French, known dementia, and major depressive disorder. Depending on the workload of the center the study was proposed to a random sample of patients meeting inclusion criteria. A total of 213 patients were recruited, of whom 12 were excluded from analysis: in 7 a diagnosis was not made, in 4 dementia had been previously diagnosed, and 3 patients had previously visited a memory clinic. The remaining 201 patients were included. The participant characteristics are summarized in Table 1 and the recruitment process summarized in Figure 1. Procedures F-TYM was administered prior to any cognitive assessment at the clinic under supervision of a health professional. Help was limited to clarifying instructions. The supervisor was not allowed to give answers to the patient. Once completed the F-TYM was sealed in an envelope and sent to the research center, with the attending physicians unaware of the F-TYM results (Gifford & Cummings, 1999). The patient then completed usual center procedures including the MMSE (GRECO version) (Puel & Hugonot-Diener, 1996). Mood was evaluated with the 30-item Geriatric Depression Scale (GDS-30) (Yesavage et al., 1983). Centers had the choice to conduct all tests they judged necessary for the diagnosis. Diagnosis of dementia was established according to
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Table 1. Patient characteristics. N = 201
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Female Age (years) Educational status Primary education (school)
137 (68%) 76 ± 10 (41–94;79) 101 (51%)
Secondary education (college)
43 (21%)
Higher education (university)
56 (28%)
GDS-30 (/30) MMSE (/30) Anxio-depressive disorder (anxiety or minor depression) Diagnosis Dementia No dementia
9.9 ± 5.5 (0–25;9) 24.4 ± 4.7 (5–30;25) 59 (29%) 68 (34%) 133 (66%)
No cognitive disorder*
46 (23%)
MCI
87 (43%)
Non amnestic, single domain MCI
11 (5%)
Non amnestic, multiple domain MCI
11 (5%)
Amnestic, single domain MCI
16 (8%)
Amnestic, multiple domain MCI
49 (24%)
Results are expressed as mean ± standard deviation (minimum–maximum;median) for continuous variables and as number (percentage) for categorical variables. *Patients with cognitive complaints in whom no cognitive disease is diagnosed on the initial appointment. MCI: Mild Cognitive Impairment.
Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria (Wilson & Skodol, 1994). Diagnosis of MCI was established according to European Consortium criteria (Portet et al., 2006) and Petersen criteria (Petersen et al., 1999). The diagnosis was established at the end of evaluations: no cognitive disorder, non-amnestic MCI, amnestic MCI (Gauthier et al., 2006), and dementia. The F-TYM result was analyzed independently by two physicians unaware of the diagnosis. Ethics This study was conducted in compliance with the Good Clinical Practices protocol and Declaration of Helsinki principles. Usual procedures were not modified by the patient’s participation in the study. Approval of a French Ethical Board (Comité de Protection des Personnes du Groupe Hospitalier Pitié-Salpétrière) was sought and it was confirmed that the study was non-interventional. Patients gave informed consent to participate prior to any procedure.
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213 patients recruited
12 patients excluded from analysis (diagnosis not collected
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N = 7, known dementia N = 4, had already visited a memory clinic N = 3)
201 patients analyzed
No
Dementia
Amnestic MCI
Other form of
cognitive
N = 68
N = 65
MCI
disease
N = 22
N = 46
Figure 1. Flow diagram according to diagnosis on initial appointment. No cognitive disease = patients with cognitive complaints in whom no cognitive disease is diagnosed on the initial appointment.
Statistics The main objective of the study was to assess sensitivity and specificity of F-TYM in the diagnosis of dementia. Positive and negative LR were calculated. Based on Bayes’ theorem, LR allows calculation of the probability of dementia for a patient based on the test results and the pre-test probability of dementia (estimated to be equal to prevalence in the studied population). Post-test probability was derived from pre-test odds by multiplying odds by LR. Cut-offs for the diagnosis of dementia using the F-TYM score were calculated by logistic regression and plot of a receiver operating characteristics (ROC) curve for patients with dementia compared to those with MCI or no cognitive disorders. Since amnestic disorders and dementia are on a spectrum without a clear dividing line, a further analysis was conducted excluding patients with MCI whether amnestic or not. Internal consistency was assessed with the Cronbach’s α coefficient (Cronbach, 1951), concurrent validity was assessed against MMSE and GDS-30 with Pearson correlation coefficients. Inter-rater reliability was evaluated with the intra-class correlation
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coefficient (Shrout & Fleiss, 1979). F-TYM results were compared between patients with depressed mood (GDS-30>22) and other patients using analysis of variance. F-TYM results were compared according to the final diagnosis using analysis of variance followed by post-hoc tests (Bonferroni method dealing with type I error rate inflation associated with multiple comparisons). Sample size was estimated according to the method proposed by Simel and Samsa (1991) using the following parameters: 50% of patients visiting the memory clinic would be diagnosed with dementia; sensitivity and specificity would be respectively 0.93 and 0.86 (i.e., a positive LR of 6.64 and a negative LR of 0.08; Brown et al., 2009); 194 patients were required to estimate a positive LR of 6.68 with a confidence interval (CI) of 3.3–13.3. For a 50% pre-test probability of dementia and knowing the positive results of F-TYM, the post-test probability of dementia would be included within the range 0.77–0.93. Statistical analysis was conducted with SAS 9.1 software (SAS Institute, Cary, North Carolina, USA).
RESULTS F-TYM administration F-TYM was well accepted by patients and required minimal supervision. A total of 85 patients (43%) did not require any help, 89 (44%) required minor help, 19 (10%) needed moderate help, and only 7 (3%) required major help. Mean help score was 3.5 ± 1.3/5 (mean ± SD/maximal theoretical score). Patients aged over 80 years, those with lower education level, and those with dementia required more help (p = .01, p = .02 and p = .01 respectively). F-TYM score The mean F-TYM total score was 38.4 ± 8.6. The score was not normally distributed (Kolmogorov-Smirnov test, p < .01) with a ceiling effect. Scores were lower in older patients (p < .0001) even in patients without cognitive disorders (p = .004). F-TYM score was lower in poorly educated patients compared to the whole population (p < .0001). However, when examining only patients without cognitive disorders, there was no influence of educational level after adjustment on age (p = .34). F-TYM validation Cronbach α was 0.83 showing excellent internal consistency. F-TYM score was highly correlated with MMSE (Pearson’s correlation coefficient r = .78, p < .0001). There was no correlation between F-TYM score and GDS-30 (r = –.03, p = .66) indicating that the F-TYM test was not influenced by mood in these patients with no known major depressive episode. Inter-rater agreement was excellent; intraclass correlation coefficient = 0.99; 95% CI (0.987–0.992).
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Utility of F-TYM for screening of dementia and MCI
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F-TYM score was 43.5 ± 6.6 in patients without organic disorders, 44.3 ± 4.5 in patients with non-amnestic MCI, 40.5 ± 6.3 in patients with amnestic MCI, and 30.9 ± 7.6 in patients with dementia (p < .0001). Similar results were found after adjustment on age, sex, and educational level. There was no difference in the overall F-TYM score between amnestic MCI patients, non-amnestic MCI patients and patients without cognitive disorder (Table 2).
Table 2. F-TYM score. F-TYM score All patients (N = 201)
38.35 ± 8.61
Influence of sex Male (N = 64)
38.05 ± 9.24
Female (N = 137) Influence of age < 70 years old (N = 51)
0.73
38.50 ± 8.33
41.63 ± 8.30
70-80 years old (N = 59)
40.27 ± 8.53
≥80 years old (N = 91)
35.27 ± 7.84
Influence of education Primary education (N = 101)
p value
< .0001
35.93 ± 7.94
Secondary education (N = 43)
38.88 ± 8.09
Higher education (N = 56)
42.29 ± 8.99
GDS-30 < 15 (N = 143)
37.94 ± 8.79
15-22 (N = 34)
38.56 ± 8.42
> 22 (N = 4)
41.75 ± 7.32
Diagnosis No cognitive disorder (N = 46)
43.46 ± 6.62
Non amnestic MCI (N = 22)
44.27 ± 4.50
Amnestic MCI (N = 65)
40.51 ± 6.35
Dementia (N = 68)
30.93 ± 7.56
< .0001
0.69
< .0001*
Results are expressed as mean ± standard deviation; *differences are significant between dementia and each other diagnosis (Bonferroni post hoc test). MCI: Mild Cognitive Impairment.
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Considering each subscore separately, all but the ability to copy a sentence were significantly lower in patients with dementia compared to patients without cognitive disorder (p < .0001). Patients with non-amnestic MCI scored similarly to patients without cognitive disorder for each subscore. Patients with amnestic MCI scored lower than patients with no cognitive disorders or non-amnestic MCI on recall. A F-TYM score ≤ 39 had 0.90 sensitivity and 0.70 specificity regarding the diagnosis of dementia (area under the curve 0.88 95% CI, 0.83–0.92; Figure 2). Positive LR was 2.98 (95% CI, 1.59–5.59), negative LR was 0.15 (0.07–0.31) compared to all other patients—including those with MCI. Among 101 patients with F-TYM score ≤ 39, 61 (60.4%) were diagnosed with dementia. In 100 patients with F-TYM score > 39, 7 (7.0%) were diagnosed with dementia. Therefore the false positive rate was 39.6% and the false negative rate was 7.0%. A further analysis was conducted assessing the F-TYM properties to distinguish patients with dementia from those with no cognitive diagnosis. A F-TYM score ≤ 40 had 0.93 sensitivity and 0.76 specificity regarding the diagnosis of dementia (area under the curve 0.90. 95%, CI 0.88–0.96; Figure 3). The optimal cut-off value of MMSE for diagnosis of dementia in the studied population was 24 (sensitivity 0.88, specificity 0.83, positive LR 5.29 [2.11–13.25], negative LR 0.14 [0.08–0.28]). Properties of F-TYM and MMSE are summarized in Table 3.
DISCUSSION F-TYM Despite minor cross-cultural adjustments, the F-TYM has demonstrated the same properties as the English TYM. F-TYM was well accepted by patients, administration 1 0.9 0.8 0.7
Sensitivity
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0.6 0.5 0.4 0.3 Area under the curve (AUC) = 0.88
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Figure 2. ROC curve assessing F-TYM properties for dementia screening among patients with memory complaints.
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0.7 0.6 0.5 0.4 0.3 Area under the curve (AUC) = 0.90
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Figure 3. ROC curve assessing F-TYM properties for dementia screening in a population excluding MCI patients. Flow diagram according to diagnosis on initial appointment No cognitive disease=patients with cognitive complaints in whom no cognitive disease is diagnosed on the initial appointment.
Table 3. Metrological properties of F-TYM and MMSE. F-TYM ≤ 39 Sensitivity Specificity Youden index Positive likelihood ratio Negative likelihood ratio Positive predictive value Negative predictive value Area under ROC curve
0.90 0.70 0.60 2.98 (1.59–5.59) 0.15 (0.07–0.31) 0.60 0.93 0.88
MMSE ≤ 24 0.88 0.83 0.71 5.29 (2.11–13.25) 0.14 (0.07–0.28) 0.73 0.93 0.92
was easy and required little help. Patients with dementia required more help than normal patients or patients with MCI. Internal consistency and inter-rater reliability were excellent as previously reported (Brown et al., 2009; Hanyu et al., 2011). All the subtest scores except copying were significantly impaired in patients with dementia. Our study addressed some important issues: 1. F-TYM was found to be well correlated with MMSE , it was much less timeconsuming for the physician. Internal consistency and inter-rater reliability were excellent as previously reported (Brown et al., 2009; Hanyu et al., 2011). 2. There was no effect of sex, education, and depressed mood on F-TYM results, but a significant effect of age even in patients without cognitive disorders. The absence of educational effects in patients without cognitive disorder is probably because the F-TYM is quite an easy test so there is a ceiling effect. Older
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4.
5. 6.
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patients scored lower than younger ones raising interest in setting-up cut-offs based on patients’ age for clinical practice. As there was no effect of education on the F-TYM scores then no educational correction was necessary. In countries with a lower standard of general education such a correction might be needed. Global score and subset scores except copying were significantly impaired in patients with dementia F-TYM discriminated patients with dementia from those with MCI or no cognitive disorder. The optimal cut-off score was 39 and was associated with a 0.90 sensitivity and a 0.70 specificity. F-TYM did not distinguish amnestic MCI patients from those with no cognitive diagnosis on the overall score, but did so on the recall score. F-TYM did not distinguish non-amnestic MCI patients from those without cognitive disorder, but the sample was small. F-TYM for screening dementia in participants with memory complaints
Our study did not reproduce the results of the index study (Brown et al., 2009). Mean F-TYM was 31 ± 8 in patients with dementia and 43 ± 6 in normal patients, while it was 33 and 47 respectively in the index study. We found that the optimal cutoff for screening dementia was 39 with a 90% sensitivity and a 70% specificity, a lower value than the cut-off of 42 proposed in the index study (sensitivity 93%, specificity 86%). Such differences could be due to (1) differences in methods, (2) differences in the definition of dementia, and (3) differences in severity of dementia. First, the index study was a case-control study in which cases and controls were age-matched and controls were patient’s relatives with no history of neurological disease, memory problems, or brain injury. Our study was conducted in in memory clinics with patients with memory complaints; thus, our “control” patients were patients with memory complaints in whom no cognitive disorder was diagnosed after extensive assessment. Recruitment of patients with AD and normal controls partially explains an over-estimation of specificity when compared to a cohort in which all patients had memory complaints. In a study conducted on consecutive patients in two memory clinics, the authors (Hancock & Larner, 2011) found an optimal cut-off of 30 with high positive LR (6.28) but low sensitivity (73%). Second, in the index study patients with amnestic MCI and poor results on the Addenbrooke’s cognitive examination were considered as patients with early AD (Morris et al., 2001) which led to a higher cut-off. Our data did not allow us to make such a distinction among amnestic MCI patients. Considering amnestic MCI patients as non-demented patients, Hancock and Larner likewise found a markedly lower optimal cut-off. Finally, severity of dementia plays a major role in the cut-off determination. In the Hancock and Larner study, mean MMSE showed that demented patients were more severely impaired than in our study. The more impaired the demented patients, the lower the expected cut-off. F-TYM for screening MCI in participants with memory complaints AD is a progressive disease. Some but not all MCI may be considered as prodromal stages of AD. Current treatments do not cure or alter the progressive course
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of dementia (Lorentz, Scanlan, & Borson, 2002) but other measures (such as treatment of comorbid conditions, initiation of psychosocial support) may be useful at early symptomatic stages. The F-TYM was not found appropriate to detect MCI and its different variants, which is also true for the MMSE (Villarejo & Puertas-Martin, 2011). This has also been recognized with the index version (Brown et al., 2009). Patterns of scores may be more useful than the overall score for diagnosing amnestic MCI. Indeed we found that patients with amnestic MCI performed as patients without cognitive disorders on all subtests except sentence recall. In the validation process of the Japanese version of TYM, the authors (Hanyu et al., 2011) found that a cut-off score of 44/50 may discriminate patients with MCI from patients with no cognitive disorder because they performed significantly worse on orientation, semantic knowledge, anterograde memory, and executive function. Their validation study, however, was not conducted in usual clinical setting conditions but reproduced methods of the index study.
F-TYM in clinical practice Patients referred in the participating centers are not representative of the general population. In our study final diagnosis was dementia in 34% of patients, amnestic MCI in 32%, non-amnestic MCI in 11%, and absence of cognitive disorder in 23%. Numbers would be quite different in a primary care setting with a lower frequency of dementia. The high frequency of dementia produced more precise estimations of LR. The post-test probabilities (i.e., proportion of patients with dementia in patients with F-TYM ≤ 39) can be calculated by multiplying pre-test odds by positive LR. For example, assuming a prevalence of 10% of dementia, the probability for a patient to be diagnosed with dementia knowing the TYM-test score is ≤ 39, is 0.25. Slightly better results are expected with MMSE ≤ 24 which appeared to be the optimal cut-off value in our study giving an expected post-test probability of 36%. It should be remembered that we have considered MCI patients as not demented. Today no single tool is recognized as the “gold standard” for detection of cognitive impairment in primary care. Numerous tools apart from MMSE have been proposed. Among them General Practitioner Assessment of Cognition (GPCOG), MiniCog and Memory Impairment Screen (MIS) appeared to be most suited for primary care (Brodaty, Low, Gibson, & Burns, 2006; Ismail, Rajji, & Shulman, 2010; Lorentz et al., 2002; Milne, Culverwell, Guss, Tuppen, & Whelton, 2008). They require only a little time to be administered and have little or no educational bias. Nevertheless they have some limitations. GPCOG requires an informant score to assess as pass or fail; MIS does not test executive functions or visuospatial skills. Mini-Cog and MIS are copyrighted but the owners allow free use by clinicians. All these tests are administered by the physician. By contrast F-TYM is free of charge, requires only little if any medical supervision, and explores 10 domains of cognitive function. The TYM has clear advantages over the MMSE testing a wider range of cognitive skills more thoroughly than the MMSE. In most validations (e.g., Brown et al., 2009; Hanyu et al., 2011) it has performed far better than the MMSE. In addition because it is filled in by the patient under minimal supervision it can be administered in a busy clinic with little disruption in a very short time. The Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005)
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has a similar level of difficulty to the TYM and is gaining popularity but like the MMSE takes several minutes of dedicated time to administer.
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Perspectives F-TYM appears to be an easy to use and user-friendly tool that numerous primary care physicians and nurses may find appropriate for a daily use. Hancock recommends using relatives of patients to administer the test and save medical time (Hancock & Larner, 2011). Scoring is fairly easy and instructions and scoring sheets are available from the websites tymtest.com and self-measurement.com. The F-TYM test is neither a diagnostic tool for dementia nor a substitute for a clinical assessment. It is intended to be used to actively screen patients with dementia among patients complaining of memory loss. F-TYM is a way to examine cognitive function in a formal way. The F-TYM score can aid the decision on whether to refer a patient to a memory clinic. Choice of cut-off must be driven by the needs of the particular clinical situations. Identifying as many cases as possible is associated with a higher false positive rate; inversely aiming at restricting the number of false positive means accepting to diagnose fewer cases. The main objective should be the diagnosis of early cognitive impairments, an objective that would be more important once there are effective treatments for AD. Currently diagnosis of dementia is important in the medical and social management of patients. We recommend three grades of risk: very low risk of dementia (F-TYM > 42), slight risk of dementia (39< F-TYM≤42), and high risk of dementia (F-TYM≤39). These limits are highly sensitive to the study conditions (population, age, prevalence of dementia, severity of cognitive impairment in demented patients). In all cases the final diagnosis of dementia must be made on a clinical basis by trained physicians. Consequences of a wide use of the F-TYM by primary care physicians need further evaluation.
ACKNOWLEDGMENT Novartis gave an unrestricted grant for the conduct of the study. The authors thank the patients who kindly participated in this study and the investigators who have contributed to the conduct of this study.
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