Psychiatry Research 216 (2014) 291–302

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Psychiatry Research journal homepage: www.elsevier.com/locate/psychres

Review article

Systematic review of appropriate cognitive assessment instruments used in clinical trials of schizophrenia, major depressive disorder and bipolar disorder Nadia Bakkour a, Jennifer Samp b, Kasem Akhras b, Emna El Hammi a, Imen Soussi a, Fatma Zahra a, Gérard Duru c, Amna Kooli a, Mondher Toumi c,n a b c

Creativ-Ceutical, 500 Lake Cook Road #350, Deerfield, IL, USA Takeda Pharmaceuticals International, One Takeda Parkway, Deerfield, IL, USA University of Lyon, University Claude Bernard Lyon I, UFR d'Odontologie, 11 rue Guillaume Paradin, 69372 Lyon, Cedex 08, France

art ic l e i nf o

a b s t r a c t

Article history: Received 11 July 2013 Received in revised form 3 February 2014 Accepted 9 February 2014 Available online 3 March 2014

Cognitive dysfunction is increasingly recognized as a symptom in mental conditions including schizophrenia, major depressive disorder (MDD), and bipolar disorder (BPD). Despite the many available cognitive assessment instruments, consensus is lacking on their appropriate use in clinical trials. We conducted a systematic literature review in Embase, PubMed/Medline and PsychINFO to identify appropriate cognitive function instruments for use in clinical trials of schizophrenia, MDD, and BPD. Instruments were identified from the articles. Instruments and articles were excluded if they did not address schizophrenia, MDD, or BPD. Instrument appropriateness was further assessed by the criteria of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative: test–retest reliability, utility, relationship to functional status, potential changeability to pharmacological agents, and tolerability and practicality for clinical trials. The database search yielded 173 articles describing 150 instruments used to assess cognitive function. Seventeen additional instruments were identified through Google and clinicaltrials.gov. Among all these, only 30 (18%) were deemed appropriate for use in the diseases of interest. Of these, 27 were studied in schizophrenia, one in MDD and two in BPD. These findings suggest the need for careful selection of appropriate cognitive assessment instruments, as not all may be valid in these disorders. & 2014 Elsevier Ireland Ltd. All rights reserved.

Keywords: Bipolar disorder Cognitive dysfunction Cognitive instrument Major depressive disorder Schizophrenia

Contents 1. 2.

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292 Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292 2.1. Search strategy for articles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292 2.2. Search strategy for instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292 2.3. Identification of appropriate cognitive function instruments in schizophrenia, MDD and BPD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292 2.3.1. Data collection and synthesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292 2.3.2. Frequency of use of instruments in clinical trials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293 3. Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293 3.1. Instrument identification through database search and overview of articles reviewed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293 3.2. Review of appropriate cognitive function instruments in schizophrenia, MDD and BPD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297 3.3. Cognitive domains measured by selected instruments in schizophrenia, MDD and BPD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297 3.4. Frequency of instruments' use in clinical trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297 4. Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 298 Conflict of interest: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 299 Funding support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300

n

Corresponding author. Tel.: þ 33 4 78 77 10 52; fax: þ33 1 53 75 49 24. E-mail address: [email protected] (M. Toumi).

http://dx.doi.org/10.1016/j.psychres.2014.02.014 0165-1781 & 2014 Elsevier Ireland Ltd. All rights reserved.

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Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300 Appendix A. Supplementary materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300

1. Introduction A cognitive disorder is any medical condition that affects how the brain processes and stores information, resulting in the impairment of memory, attention, perception, and thinking (Barlow and Durand, 2011). These impairments can lead to reduced productivity, diminished social functioning, and decreased quality of life (QoL). In the last decade, there has been an increasing appreciation of cognitive impairments in patients with mental disorders such as schizophrenia, major depressive disorder (MDD), and bipolar disorder (BPD). To date, extensive research has been conducted in schizophrenia highlighting a range of cognitive abnormalities. Schizophrenia cognitive deficits are believed to involve seven domains of cognitive function: speed of processing (Tabares-Seisdedos et al., 2008), attention/vigilance (Prouteau et al., 2005), working memory (Tabares-Seisdedos et al., 2008), verbal learning, visual learning, reasoning and problem solving (Fett and Maat, 2013), and social cognition (Hofer et al., 2010). Establishing evidence of cognitive deficits in other mood disorders has been slower. Some studies have shown that patients with BPD have persistent impairments in neuropsychological function, particularly in the domains of reasoning and problem solving and declarative memory (Ferrier et al., 2004; Szoke et al., 2006; Mur et al., 2008). Other reports viewed cognitive impairments as trait abnormalities in euthymic young people with bipolar disorder (Kolur et al., 2006). More recent MDD research has demonstrated the presence of deficits in key cognitive functions in patients with acute major depressive episodes (Hasselbalch et al., 2011). As mental health disorders are increasingly associated with cognitive dysfunction, assessment of cognitive dysfunction has increased in importance. The demand for sensitive and appropriate cognitive assessment instruments has escalated, especially for use in clinical trials. However, consensus is lacking on the appropriate instruments in these disease states. To qualify as appropriate, a cognitive assessment instrument must be tested in target populations of interest and must discriminate between cognitively healthy individuals and persons experiencing subtle cognitive changes. For example, the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) are used in screening for initial stages of Alzheimer's disease; however, these instruments have not been tested for use in schizophrenia, MDD or BPD (Huang et al., 2009; Morley, 2013). To our knowledge, there is no study available that has summarized and evaluated the currently available cognitive assessment instruments for use in clinical trials of mental health disorders. Therefore, the aim of this study was to generate a list of appropriate instruments for evaluating cognitive function for use, specifically in clinical trials, in patients with schizophrenia, MDD, and BPD. A systematic literature search was done to identify instruments.

2. Methods 2.1. Search strategy for articles A systematic search of the Embase, PubMed/Medline and PsycINFO electronic databases was performed to identify cognitive assessment instruments with documented use in schizophrenia, MDD, and BPD. Search results were limited to humans, English language, and articles with abstracts. As the purpose of this study

was to list all instruments currently used in clinical trials, we also limited our search to articles published between the years 2000 and 2012. Abstracts were reviewed for all inclusion/exclusion criteria. Included articles involved (1) the study population included patients with schizophrenia, MDD and/or BPD and (2) the instrument was psychometrically valid (i.e. reliable, valid, and responsive). Articles were excluded if (1) the topic disease was not of interest, (2) the instrument did not measure cognitive function, or (3) the study was a cross-validation of the instrument in another language or country.

2.2. Search strategy for instruments The abstracts of all identified articles were screened for use of cognitive assessment instruments. Instruments included individual instruments (i.e. single cognitive test) or batteries of instruments (i.e. the compilation of multiple cognitive tests). An ad hoc search was similarly performed in Google and clinicaltrials.gov to ensure comprehensiveness of the final list. The identified list of instruments was screened for use in one of the three diseases of interest. Each instrument was reviewed and excluded if it was (1) not an instrument for cognitive function assessment, (2) not an appropriate instrument based on MATRICS criteria (to be described below), (3) a sub-instrument of a battery of instruments that was already included, (4) not a scale (i.e. guidelines, initiatives, etc.) (5) used only once or by a single author, or (6) not informative to clinicians (did not inform the clinician on measures to take). Instruments were also excluded if there were duplicates from cross-validation in another language or country.

2.3. Identification of appropriate cognitive function instruments in schizophrenia, MDD and BPD All instruments retrieved from the literature search were assessed for appropriate use in clinical trials based on five recommendations for a cognitive consensus battery that were developed by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative (Green et al., 2004). The MATRICS program was designed by the National Institute of Mental Health (NIMH) to support the development of pharmacological agents for improving the neurocognitive impairments in schizophrenia (Gaebel, 2011). This initiative formed a subcommittee of experts to develop a set of recommendations for a cognitive consensus battery for schizophrenia. The five pre-set criteria included: test–retest reliability, utility as a repeated measure, relationship to functional outcome, potential changeability in response to pharmacological agents, and tolerability and practicality for clinical setting. The validity and reliability of these instruments were reviewed by two independent experts and in-house statisticians based on all the relevant scientific literature on each measure, and considering several criteria such as: the type of statistic used to measure reliability, the time interval between testings, correlation with a comprehensive battery, internal consistency of the global score, whether the data are from normal or clinical samples, etc. The resellers of each scale were also separately contacted to provide relevant sources on validity and to confirm the information retrieved by our internal search.

2.3.1. Data collection and synthesis Articles that met all inclusion and exclusion criteria were described in terms of studied population, study type, study size, patient characteristics at baseline (age, sex), cognitive assessment instrument, type of cognitive domain (classified according to the list of cognitive domains provided by the MATRICS initiative) and number of cognitive domains measured. A list of appropriate instruments that evaluate cognitive function in schizophrenia, MDD, or BPD patients was generated from the articles. The instruments were classified as subtests, scales or batteries where a subtest was a component of an instrument that measured a specific area/domain, a scale was a single instrument, and a battery was a compilation of multiple cognitive instruments. The instruments were analyzed by subpopulations of age category (adult, child, and elderly), measured outcomes, availability of normative data and the assessed cognitive domains. Additionally, each instrument or battery was described by year of publication, disease(s), administration time, scoring type, studied age range, number of questions or subtests, and nature of the measurement: self-report measure, performance-based rating, interview-based rating. A performance-based rating instrument indicated an instrument whose score is based on the number of correct items a patient received. An interviewer-based rating instrument indicated an instrument whose score was dependent on the based on the subjective assessment by the interviewer.

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Fig. 1. Flowchart of articles screening and cognitive instrument selection process. The database searches as described in the “Materials and Methods” section generated 173 articles. Studies were selected according to the different steps outlined in this figure. Each screening step takes into consideration inclusion or exclusion factors described in the “Materials and Methods” section. The number of publications selected, added or deducted is mentioned in this chart. Records found after our database search were screened to extract an exhaustive list of 150 instruments to which 17 additional instruments were added after an ad hoc research in Google and clinical trials.gov. All 167 instruments were reviewed of which 137 were excluded. We finally obtained a list of 30 cognitive assessment instruments.

2.3.2. Frequency of use of instruments in clinical trials Of the instruments identified from the articles, their frequency of use in clinical trials was determined by searching the clinicaltrials.gov database. For each instrument, an advanced search was conducted using the instrument's full name OR acronym as “search terms” and schizophrenia OR major depressive disorder OR bipolar disorder in the “conditions” field.

3. Results 3.1. Instrument identification through database search and overview of articles reviewed One hundred thirty-six studies were identified through the search of Embase and PsychINFO. The Pubmed/Medline search yielded 37 additional articles. A total of 173 abstracts were screened to extract the name of the cognitive function instruments. A total of 150 instruments were identified, and 17 instruments were added following an ad hoc search on Google and clinicaltrials.gov. After reviewing the 167 instruments, 137 were excluded because they did not meet the eligibility criteria: six were found not to be a scale (e.g. Cognitive Neuroscience

Treatment to Improve Cognition in Schizophrenia (CNTRICS)), 96 were not specific to cognition (e.g. Mindreading, Irrational Food Beliefs Scale), 21 were not appropriate instruments for cognitive assessment (did not meet MATRICS criteria) either because they were used only once (e.g. Vocational Cognitive Rating Scale, 25-min battery of computer-based tests, workreadiness cognitive screen (WCS)) or because of lack of reliability and validity (e.g. Self-Assessment Scale of Cognitive Complaints in Schizophrenia (SASCCS), Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ), Rust Inventory of Schizotypal Cognitions (RISC)), four were cross-validations (e.g. Screen for Cognitive Impairment in Psychiatry (SCIP-S)), seven were sub-instruments of batteries (e. g. Picture Arrangement (PAR) subtest of the Wechsler Adult Intelligence Scale-Revised (WAIS-R)), and three were not informative scales to the clinician (e.g. Digit symbol Wechsler Adult Intelligence Scale Subtest). Finally, a list of 30 cognitive instruments was obtained. Only the papers that discussed the 30 selected instruments were included (see list of the 49 articles in Appendix). The flowchart for inclusion and exclusion of the instruments/articles is shown in Fig. 1.

294

Table 1 Properties of cognitive instruments. Name of battery/ instrument

Primary publication/revision Number of subtests/ items

Battery Lotca II tests

Itzkovich et al. (2000)

Disease

Age category

Schizophrenia Adults Six Elderly subtests: 26 items

Administration time (min)

Normative data

Likert index/classification

Measurement type

Validation source(s)

45

Schizophrenia patient-andcaregiver pairs Age

Performance-based rating

Cooke et al. (2006)

Education Ethnicity Martial status

1¼ Patient fails to perform the task 2¼ Patient is able to perform part of the task 3¼ Patient is able to perform most of the task 4¼ Patient demonstrates good performance of the task

Gender

NA

Eight subtests

Schizophrenia ND

45

NA

ND

Performance-based rating

Keefe et al. (2004)

BACS

Keefe et al. (2004)

Six subtests

Schizophrenia ND

30

Age Education Gender

NA

Performance-based rating

Keefe et al. (2004) and Keefe et al. (2006b)

BCIS

Beck et al. (2004)

Schizophrenia Adults Two Elderly subtests: 15 items

5–10

NA

4-point Likert scale: 0¼ Do not agree at all 1¼ Agree slightly 2¼ Agree a lot 3¼ Agree completely

Self-report measure

Greenberger and Serper (2010) and Martin et al. (2010)

CANTAB

Sahakian et al. (1988)

22 subtests

Schizophrenia Children Adults Elderly

40–45

NA

NA

Performance-based rating

Falconer et al. (2010)

CAS

Dejong and Overholser (2007)

One scale: 23 items

MDD

ND

NA

5-point Likert scale 0¼ not at all 1¼ a little bit 2¼ somewhat 3¼ a fair amount 4¼ very much

Self-report measure

Dejong and Overholser (2007)

CGI-CogS

Bilder et al. (2003)

Two categories: 38 items

Schizophrenia ND

30–40

Schizophrenia Patient-andcaregiver pairs, Age, Gender, Education, Ethnicity, Martial status

7-point Likert scale Interview-based measure with Ventura et al. (2008) 1¼ normal, not at all three sources of information impaired (patient, caregiver, and rater) 7¼ severe cognitive deficits

CogStateBattery Makdissi et al. (2001)

Eight scales

Schizophrenia Children Adults Elderly

35

NA

NA

Computerized performance based measure

Pietrzak et al. (2009) and Maruff et al. (2009)

Cogtest

Cogtest (2001)

32 scales

Schizophrenia ND

60

NA

Standard Scores (SS) Z 115 ¼Above Average SS 86-114¼ Average SS 71-85 ¼Below Average SS o 71 ¼Well Below Average

Computerized performance based measure

Sharma and Bilder (2004)

CVLT

Delis et al. (1987), 2000

Four subtests

Schizophrenia Adults Elderly

30

Age, Gender, Educational level, Ethnicity

ND

Performance-based rating

Delis et al. (1988) and Schear and Craft (1989)

ND

N. Bakkour et al. / Psychiatry Research 216 (2014) 291–302

BAC-A

HAPPI

Mansell and Jones (2006)

BPD One scale: 30 items for Brief-HAPPI

IntegNeuro™

Gordon et al. (2005)

13 subtests

ND

Schizophrenia Children Adults Elderly

ND

Intellectual ability, Gender, Age NA

Self-report questionnaire

Dodd et al. (2010) and Dodd et al. (2011)

60

Age, Education

Computerized performance based measure

Paul et al. (2005) and Silverstein et al. (2010)

98thr Very superior r 100th 91th r Superioro 98th 75thr High averageo 91th 25thr Averageo 75th 9thr Low average o25th 2ndr Borderline o9th Extremely low o 2nd

Nuechterlein and Green (2006)

10 scales including 62 subtests

Schizophrenia Adults

60–90

Age, Gender, Educational level, Ethnicity

ND

Performance-based rating

Nuechterlein et al. (2008)

BACS: Symbol codinga

2004

One task

Schizophrenia ND

3

Age, Education, Gender

NA

Performance-based rating

Keefe et al. (2004)

BVMT-Ra

Benedict (1996) and Benedict et al. (1996)

One task

Schizophrenia Adults Elderly

5

Age, Gender

ND

Performance-based rating

Benedict et al. (1996)

Category Fluency: Animal naminga CPT-IP (Identical Pairs)a

Goodglass and Kaplan (1972) One task

Schizophrenia ND

2

Age, Education

ND

Performance-based rating

Tombaugh et al. (1999)

(Cornblatt et al., 1988)

One task

Schizophrenia Adults

13–14

Age, Education, Gender

ND

Computerized performance based measure

Cornblatt et al. (1988)

HVLT-Ra

Benedict et al. (1998) and Brandt and Benedict (2001)

12 items

Schizophrenia Adults Elderly

4

Age, Gender

ND

Performance-based rating

Benedict et al. (1998), Shapiro et al. (1999) and Lacritz et al. (2001)

Letter Number Spana

Gold et al. (1997)

One task

Schizophrenia Adults Elderly

6

Age, Gender

ND

Performance-based rating

Gold et al. (1997)

MSCEITa

Mayer et al. (2002)

141 items

Schizophrenia Adults

12

Age, Gender Educational level, Ethnicity

Z 69: Consider Development 70-89: Consider Improvement 90-99: Low Average Score 100-109: High Average Score 110-119: Competent 120-129: Strength þ 130: Significant Strength

Self-administered, performance-based rating

Brackett and Mayer (2003) and Roberts et al. (2006)

Stern and White (2003)

One task

11

Age, Gender

ND

Performance-based rating

Ott et al. (2003)

(TMT, Army Individual Test Battery, 1944)

One task

Schizophrenia Adults Elderly Schizophrenia ND

2

Age, Education, Gender

ND

Performance-based rating

Sanchez-Cubillo et al. (2009)

Wechsler (1997)

13 subtests

Schizophrenia Adults

5

Age, Gender

Average: 25-100%

Performance-based rating

(NAB): Mazes Trail Making Test Aa

a

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MCCB

295

296

Table 1 (continued ) Name of battery/ instrument

Primary publication/revision Number of subtests/ items

Disease

Wechsler Memory Scale-3RD eda

Age category

Administration time (min)

Normative data

Elderly

NeuroTrax Corp (2003)

9 subtests

RBANS

Randolph (1998)

12 subtests

SCD

Bazin et al. (2005)

SCoRS

Measurement type

Validation source(s)

Low average: 10-24% Borderline: 5-9% Low 2-4% Very low o 2%

Uttl and Graf (1999) and Price et al. (2002)

ND

Computerized performance based measure Very superior (index score: Performance-based rating 130 or above, theoretical percent: 2.2%) Superior (120–129, 6.7%) High average (110 119, 16.1%) Average (90–109, 50%) Low average (80–89, 16.1%) Borderline (70–79, 6.7%) Extremely low (69 and below, 2.2%)

Dwolatzky et al. (2004) Gold et al. (1999) and Hobart et al. (1999)

Schizophrenia Adults Elderly Schizophrenia Adults Elderly

40–60

NA

25–30

Age Education

One scale: 7 items

Schizophrenia ND

30

Gender, Age, Education period of illness

3-point scale: 0¼ absent inability 1¼ slight inability 2¼ moderate inability 3¼ severe inability

Interview-based measure

Bazin et al. (2005)

Keefe et al. (2006c)

One scale: 18 items

Schizophrenia ND

12–15

NA

4-point rating scale : 1¼ None 2¼ Mild impairment 3¼ Moderate 4¼ Severe impairment

Interview-based measure

Keefe et al. (2006c)

SoCT

Jarrett et al. (2011)

One scale: 8 items

MDD

ND

Gender, Profession, Age

Patients' self-ratings and 5-point Likert-type scale ranging from 1 (never) to 5 clinicians' ratings (always or when needed)

Jarrett et al. (2011)

WAIS-R

Wechsler (1981, 2008)

15 subtests

Schizophrenia Adults Elderly

60–90

Age Gender Educational level

Very Superior: 130 & above Performance-based rating Superior: 120–129 High Average: 110–119 Average: 90–109 Low Average: 80–89 Borderline: 70–79 Extremely Low: 69 and below

Canivez et al. (2009)

WISC-III

Wechsler (1991, 2003)

15 subtests

Schizophrenia Children

65–80

Age

Very superior:130þ Superior: 120–129 High average: 110–119 Average: 90–109 Low average: 80–89 Borderline: 70–79 Extremely low: 69 Mild mental retardation: 55–69

Performance-based rating

Williams et al. (2003a) and Williams et al. (2003b)

WRAT

Jastak and Bijou (1946), Wilkinson and Robertson

Four subtests

Schizophrenia Children Adults

35–45

Age

Very superior: 130þ Superior: 120–129

Performance-based rating

Sylvester (2008)

Adults

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Mindstreamss

Likert index/classification

a Instrument part of MCCB battery. NA and ND refer to ‘not available’ and ‘not determined’ data respectively. BAC-A: Brief Assessment of Cognition for Affective disorders. BACS: Brief Assessment of Cognition in Schizophrenia. BCIS: Beck Cognitive Insight Scale. CANTAB: Cambridge Neuropsychological Test Automated Battery. CAS: Coping Attitude Scale. CGI-CogS: Clinical Global Impression of Cognition in Schizophrenia. CogState: CogState Schizophrenia Battery. Cogtest: Computerized neurocognitive battery. CVLT: California Verbal Learning Test. HAPPI: Hypomanic Attitudes and Positive Predictions Inventory. MCCB: MATRICS Consensus Cognitive Battery. BVMT-R: Brief Visualspatial Memory Test Revised. CPT-IP: Continuous Performance Test-Identical Pairs. HVLT-R: Hopkins Verbal Learning Test-R scores. NAB: Neuropsychological assessment battery. Mindstreams: Mindstreams Computerized Cognitive Test Battery. MSCEIT: Mayer-Saovey-Caruso Emotional Intelligence Test. RBANS: Repeatable Battery for the Assessment of Neuropsychological Status. SCD: Schizophrenia Communication Disorder Scale. SCoRS: Schizophrenia Cognition Rating Scale. SoCT: Skills of Cognitive Therapy. WAIS-R: Wechsler Adult Intelligence Scale-Revised. WISC-III: Wechsler Intelligence Scale for Children. WRAT: Wide Range Achievement Test.

Validated instruments or battery of instruments are listed in alphabetical order. Each instrument extracted is screened for year of publication or revision, number of subtests or items, disease affiliation, age range, administration time, information on normative data, classification according to the Likert index or other and the nature of the measurement (Self-report measure, performance-based rating, interview-based rating). Instruments included individual instruments (i.e. single cognitive test or scale) or batteries of instruments (i.e. the compilation of multiple cognitive tests). Each test may comprise one or more areas or categories and each area is further divided into subtests. A subtest is a group of items (tasks or questions).

(2006) and Pietrzak et al. (2009)

Elderly

High average: 110–119 Average: 90–109 Low average: 80–89 Borderline: 70–79 Deficient: 69

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3.2. Review of appropriate cognitive function instruments in schizophrenia, MDD and BPD Among the final selected articles, 27 instruments were used to assess cognitive function in schizophrenia (Table 1). Articles showed two instruments were used in MDD [the Coping Attitudes Scale (CAS) and the Skills of Cognitive Therapy (SoCT)] (Jarrett et al., 2011) and one was used in BPD (Hypomanic Attitudes and Positive Predictions Inventory: HAPPI). Of the 30 instruments, most were designated for use in adults and/or the elderly. There were five instruments that were appropriate for use in children and 10 instruments that did not specify an age. The administration time for the instruments varied from 5 to 90 min, with a mean administration time of 36 min (S.D. 20.6 min). Sub-instruments from a battery could take as little as 1 min to administer. Normative data relative to each scale are documented in instruments for which these were available (Table 1). Normative data by age were available for 22 instruments and by gender and/or education for most of these. Some instruments had other normative data including ethnicity, marital status, profession, and period of illness. Normative data were not found for 8 of the instruments [Brief Assessment of Cognition for Affective disorders (BAC-A)], Beck Cognitive Insight Scale (Fu et al., 2005), Cambridge Neuropsychological Test Automated Battery (Falconer et al., 2010), CAS, CogState Schizophrenia Battery (Pietrzak et al., 2009), Computerized neurocognitive battery (Cogtest), Mindstreams Computerized Cognitive Test Battery (Mindstreams) and Schizophrenia Cognitive Rating Scale (SCoRS). Finally, these instruments measured cognitive function with either a self-report assessment (n ¼3 instruments) or based on the clinician rating, either by a performance-based rating (n ¼23 instruments) or by an interview-based rating (n ¼3 instruments). One instrument (SoCT) uses both the patient self-report and the physician's (or caregiver's) evaluation. The eight items in SoCT assess patients' understanding and use of basic cognitive (CT) skills rated from the perspectives of both observers and patients. Ratings of patients' skills are based on a 5-point Likert-type scale ranging from 1 (“never”) to 5 (“always or when needed”). Higher scores reflect greater patient skill in applying cognitive principles and coping strategies (Jarrett et al., 2011). 3.3. Cognitive domains measured by selected instruments in schizophrenia, MDD and BPD Most instruments and/or batteries assess only one domain representing a single task (e.g. Trail Making Test A or Letter Number Span) (Table 2). Instruments measuring only one cognitive domain are generally shorter to administer ( 15 min) and address domains that are more heavily impaired (Prouteau et al., 2005; TabaresSeisdedos et al., 2008; Bonnin et al., 2012; Fett and Maat, 2013), with a great impact on QoL (Aksaray et al., 2002; Bonnin et al., 2012), functioning (Dickerson et al., 2004; Herman, 2004; Prouteau et al., 2005; Tabares-Seisdedos et al., 2008; Hammar and Ardal, 2009) and activities of daily living (Schretlen, 2007; Canuso et al., 2005). About one-third of instruments measure at least four of the seven cognitive domains. Four batteries (CANTAB, Cogtest, IntegNeuro and Neuropsychological Assessment Battery: NAB) as well as the MATRICS Consensus Cognitive Battery (MCCB) address all seven cognitive domains known to be impaired in schizophrenic patients. This latter battery was developed by the MATRICS initiative and is recommended by the FDA for use in clinical trials of cognitiveenhancing therapies. 3.4. Frequency of instruments' use in clinical trials Most of the instruments have been used at least once in a clinical trial (Table 3). Twenty-two of the instruments were used in

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Table 2 Cognitive domains assessed by each instrument or battery of instruments. Cognitive domains

Disease state Instrument BAC-A BACS Battery Lotca II tests BCIS BVMT-R CANTAB CAS Category Fluency: Animal naming CGI-CogS CogState Cogtest CPT-IP (Identical Pairs) CVLT HAPPI HVLT-R IntegNeuro™ Letter Number Span MCCB Mindstreamss MSCEIT NAB RBANS SCD SCoRS SoCT Trail Making Test A WAIS-R Wechsler Memory Scale WISC-III WRAT

Speed of processing

Attention/ vigilance

Working memory

Verbal learning

Visual learning

Reasoning/problem solving

Social cognition

D, B, S

D, S

D, B, S

B, S

B, S

D, B, S

D, B, S

þ þ

þ þ

þ þ þ

þ

þ þ þ

þ

þ

þ þ

þ

þ þ

þ þ þ

þ þ þ

þ þ þ

þ

þ

þ

þ

þ

þ þ

þ

þ þ þ

þ

þ

þ þ

þ þ þ þ

þ þ

þ

þ þ

þ þ

þ þ þ þ

þ þ

þ þ

þ þ

þ

þ

þ þ

þ

þ

þ

þ

þ þ

þ þ

þ

þ

þ

þ þ þ

þ þ þ þ

þ þ þ þ

þ þ þ þ

þ þ þ

þ þ þ

This table summarizes the different domains assessed per instrument as they are indicated with a ( þ). Each instrument or battery of instruments can address different cognitive domains at once. Specific cognitive domains are affected according to the disease; D: affected in MDD; S: affected in Schizophrenia; B: affected in BPD.

schizophrenia clinical trials, nine in MDD, and 10 in BPD trials. The MCCB was the most frequently used instrument in clinical trials (69 trials for schizophrenia, one trial in MDD and two trials in BPD). The BACS (Brief Assessment of Cognition in Schizophrenia) and CVLT (California Verbal Learning Test) were the next most frequently used instruments, in 24 and 16 clinical trials, respectively. Most instruments were used most frequently in schizophrenia clinical trials. The California Verbal Learning Test (CVLT) and the Trail Making Test A (TMT-A) were the only cognitive instruments used most frequently in BPD clinical trials. These were used in five and four trials, respectively. The CVLT is the most frequently used cognitive function instrument in MDD, followed by the TMT-A and CANTAB. Table 3 summarizes the frequency of use of each cognitive assessment instrument in clinical trials by disease.

4. Discussion With the increasing recognition of cognitive dysfunction in mental health disorders, there has been greater focus on the assessment of cognition. Many instruments are available for the assessment of cognitive functioning; however, research is still lacking on the use of these instruments in mental health disorders. Additionally, these instruments differ widely in the population intended for use, administration time, interpretation of results, and the assessment of certain cognitive domains, and little guidance is available for selection among these instruments for

clinical trials. The aim of this paper was to develop a comprehensive list of appropriate cognitive assessment instruments for use in schizophrenia, MDD and BPD clinical trials. The MATRICS initiative criteria for selection of cognitive function instruments in schizophrenia were used as the basis for determining appropriateness in this study. The set of five essential criteria was determined by the Neurocognitive Committee and a panel of 62 experts. Although these criteria were developed for cognitive assessment in schizophrenia, they are currently being validated for MDD (clinical trial number NCT00895258) and BPD (clinical trial numbers NCT01470781 and NCT00895258). To our knowledge, this is the only guidance that has been provided for assessing the appropriateness of cognitive function instruments. The present literature review identified over 150 cognitive instruments. Of this large list, only 30 were appropriate cognitive assessment instruments with the psychometric properties outlined by the MATRICS criteria. We acknowledge that this list is not exhaustive as the search was limited to the various search terms used; nonetheless it provides psychiatrists, clinicians, and other health professionals involved in such a diagnosis with a number of options when evaluating cognitive function in their patients. The low number of appropriate cognitive instruments relative to the total may indicate that we have used a strict definition to judge instrument appropriateness. Conversely, this may demonstrate that many cognitive assessment instruments lack important psychometric properties for accurately assessing cognition. In either case, clinicians and researchers should be mindful when selecting instruments for the assessment of cognitive dysfunction.

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Table 3 Frequency of use of instruments in clinical trials. Frequency of use in clinical trials

Instrument BAC-A BACS Battery Lotca II tests BCIS BVMT-R CANTAB CAS Category Fluency: Animal naming CGI-CogS CogState Cogtest CPT-IP (Identical Pairs) CVLT HAPPI HVLT-R IntegNeuro™ Letter Number Span MCCB Mindstreamss MSCEIT NAB RBANS SCD SCoRS SoCT Trail Making Test A WAIS-R Wechsler Memory Scale WISC-III WRAT

Schizophrenia

MDD

BPD

– 24 – 3 1 12 – – 1 13 – 4 6 – 7 1 7 69 – 3 1 8 1 9 – 8 2 4 1 1

1 – – – – 3 – – – – 1 – 6 – 1 – – 1 – – – – – – – 4 1 2 – –

1 2 – – – 1 – – – 2 – – 5 – 1 – – 2 – – – 2 – – – 4 – – 1 –

Frequency of use of each cognitive instrument according by disease states in clinical trials. (–) indicates that the instrument has never been used in clinical trials.

The properties of selected instruments are summarized to provide information and guidance for clinicians, researchers and test administrators. The instruments in the final list vary in administration time, measured cognitive domains, normative data, target population, and frequency of use in mental health populations. These differences may make some instruments more applicable than others in certain instances. Instruments with shorter administration times may be more appropriate for use in routine clinical practice. Those with longer administration times and more comprehensive coverage of cognitive domains may be more appropriate for use in a clinical trial setting. These results found that a comprehensive assessment of cognitive function can be achieved in as little as 30 min. Thus, clinicians may be able to implement these assessments without overwhelming time commitments. However, the benefit of shorter instruments should be weighed against any potential loss of information from not assessing certain cognitive domains (Keefe et al., 2004, 2006a, 2007). As previously discussed, instruments differed in their comprehensiveness. Some instruments assessed only one or two cognitive domains while others are battery assessments covering multiple domains. Instruments should be selected to correspond to assessment of the domains thought to be impaired in the disease state of interest. Multiple cognitive domains have been shown to be affected in schizophrenia, MDD and BPD (Bryson et al., 2001). Schizophrenia is characterized by a deficit in seven cognitive domains as previously described (Green et al., 2004). Speed of processing (Chaves et al., 2011; Bonnin et al., 2012; Daban et al., 2012), visual-scanning (Dittmann et al., 2008; Bearden et al., 2011), social cognition (Cusi et al., 2012; Lahera et al., 2013), reasoning and problem solving (Ferrier et al., 2004; Robinson et al., 2006; Szoke et al., 2006; Dittmann et al., 2008; Mur et al., 2008; Nieto

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and Castellanos, 2011; Bonnin et al., 2012; Xu et al., 2012), verbal learning, and memory (Bonnin et al., 2012; Xu et al., 2012) are the cognitive domains thought to be affected in BPD. In MDD, working memory is the cognitive domain most consistently affected (Talarowska et al., 2010; Elderkin-Thompson et al., 2011). Additionally, MDD is also associated with impairment in social cognitive performance, reasoning and problem solving (Merriam et al., 1999; Grant et al., 2001), motor speed, and attention deficits (Ilsley et al., 1995; Hammar and Ardal, 2009; Cusi et al., 2011). The instruments used in MDD (CAS and SoCT) and BPD (HAPPI) only assess social cognition; this is not consistently affected in these disorders. An instrument assessing a wider range of cognitive domains impaired in these diseases may yield better results. The use of normative data is a key element in the evaluation of cognitive function in order to appropriately classify patients as cognitively normal or cognitive dysfunctional. As reported by Mitrushina et al. (2005), each test and subtest should provide normalized values according to age, sex, education level, intelligence quotient (IQ), and ethnicity of patients. Only half of selected instruments rely on such an evaluation. To our knowledge, only one handbook provides a critical review of the normative data for most frequently used cognitive tests (Mitrushina et al., 2005). The complexity and lack of training of test administrators with regard to normative data further limit appropriate classification of cognitive dysfunction. Future researchers may wish to examine the standardization of existing instruments and comprehensive training of test administrators in order to facilitate score interpretation. In order to assess the experience of these instruments in the disease states of interest, this study examined their frequency of use in ongoing and completed clinical trials. Use of the rest of these instruments in schizophrenia clinical trials is common; however, fewer trials have used these instruments to assess cognitive deficits in MDD and BPD clinical trials. Only a few instruments were never used in a clinical context: the HAPPI and the SoCT were only recently developed, which may explain their lack of use in clinical trials. However, category fluency is part of the MCCB, and one can assume that it has been administered every time that the MCCB was administered. Although many of the identified instruments are being used in clinical trials, it is important to note that this setting is not reflective of actual clinical practice. The real-world usefulness and applicability of these instruments may be limited due to length of administration, score complexity, use of normative data, and interpretation. Therefore, differences in these aspects among these instruments may make some more suitable than others for general use. Moreover, our inclusion and exclusion criteria might have omitted other appropriate instruments from our final list. Therefore, this list may not be comprehensive and other instruments may be appropriate for the assessment of cognitive function in some populations. There are many options for instruments to assess cognitive function. This study has shown that not all instruments may meet important psychometric requirements for a valid assessment of cognitive function in schizophrenia, MDD, and BPD clinical trials. While little guidance has been provided for selecting cognitive assessment instruments, those looking to assess cognition can examine the properties of each instrument for its applicability for its intended use.

Conflict of interest: Kasem Akhras was an employee of Takeda Pharmaceuticals. Jennifer Samp was supported by a fellowship funded by Takeda Pharmaceuticals.

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Imen Soussi, Fatma Zahra, Emna El Hammi, Amna Kooli, and Mondher Toumi are employees of Creativ-Ceutical.

Funding support The study was sponsored and funded by the Takeda Pharmaceuticals, Inc. Creativ-Ceutical was contracted by Takeda to conduct the study and to provide medical writing assistance.

Acknowledgments Designed research/study: GD. Performed research/study: IS, FZ, NB. Wrote paper: NB, JS, AK, EH. Agree with manuscript results and conclusions: AK, KA, MT.

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