Psychological distress screening in cancer patients

© Il Pensiero Scientifico Editore downloaded by IP 193.204.169.200 Thu, 04 Oct 2012, 09:37:08

Tumori, 98: 501-509, 2012

Psychological distress screening in cancer patients: psychometric properties of tools available in Italy Barbara Muzzatti, and Maria Antonietta Annunziata Unit of Oncological Psychology, Centro di Riferimento Oncologico, IRCCS Istituto Nazionale Tumori, Aviano (PN), Italy

ABSTRACT

Aims and background. The main national and international organisms recommend continuous monitoring of psychological distress in cancer patients throughout the disease trajectory. The reasons for this concern are the high prevalence of psychological distress in cancer patients and its association with a worse quality of life, poor adherence to treatment, and stronger assistance needs. Most screening tools for psychological distress were developed in English-speaking countries. To be fit for use in different cultural contexts (like the Italian), they need to undergo accurate translation and specific validation. In the present work we summarized the validation studies for psychological distress screening tools available in Italian that are most widely employed internationally, with the aim of helping clinicians choose the adequate instrument. With knowledge of the properties of the corresponding Italian versions, researchers would be better able to identify the instruments that deserve further investigation. Methods. We carried out a systematic review of the literature. Results. Twenty-nine studies of eight different instruments (five relating to psychological distress, three to its depressive component) were identified. Ten of these studies involved cancer patients and 19 referred to the general population or to non-cancer, non-psychiatric subjects. For seven of the eight tools, data on concurrent and discriminant validity were available. For five instruments data on criterion validity were available, for four there were data on construct validity, and for one tool divergent and cross-cultural validity data were provided. For six of the eight tools the literature provided data on reliability (mostly about internal consistency). Conclusions. Since none of the eight instruments for which we found validation studies relative to the Italian context had undergone a complete and organic validation process, their use in the clinical context must be cautious. Italian researchers should be proactive and make a valid and reliable screening tool for Italian patients available.

Introduction In June 2011 the international journal Psycho-Oncology dedicated a monographic issue to psychological distress, a construct defined as “a multifactorial unpleasant emotional experience of a psychological (cognitive, behavioral, emotional), social, and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its physical symptoms and its treatment”1. In the editorial, Bultz and Johansen2 traced the history of 3 decades of research on this subject and highlighted the challenges that are still open. On a methodological level in particular, the authors showed how the refinement of tools and measures as well as the need to obtain good translations are still central objectives. The high prevalence of psychological distress in cancer patients and its association with a worse quality of life, poorer adherence to treatment and increased need for assistance2-5 are the main reasons that lead towards the

Key words: cancer, psychological distress, screening, reliability, validity. Acknowledgments: The authors wish to thank Ms Anna Vallerugo, MA, for her writing assistance. Correspondence to: Maria Antonietta Annunziata, Centro di Riferimento Oncologico, IRCCS Istituto Nazionale Tumori, Via F Gallini 2, 33080 Aviano (PN), Italy. email [email protected] Received October 27, 2011; accepted November 11, 2011.


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continuous and systematic monitoring of what was defined as the “sixth vital sign” in oncology6. Recently, a comprehensive, systematic survey of the literature7 identified 33 psychological distress screening tools (as an overall construct or in its components anxiety and depression) for which a validation process in oncology was started. However, the most recommended instruments that are backed by an adequate validation process are 168-22: the Beck Depression Inventory (BDI); the Brief Symptom Inventory 18 (BSI-18); the Center for Epidemiologic Studies Depression Scale (CES-D); the Combination Depression Questions; the Depression Question; the Distress Thermometer and Problem Checklist (DT+PC); the Edinburgh Postnatal Depression Scale (EPDS); the General Health Questionnaire 12 (GHQ-12); the General Health Questionnaire 28 (GHQ28); the Hospital Anxiety and Depression Scale (HADS); the Hornheide Questionnaire Short Form (HQ-9); the Post-Traumatic Stress Disorder Checklist, Civilian version (PCL-C); the Psychological Distress Inventory (PDI); the Psychosocial Screen for Cancer (PSSCAN); the Questionnaire on Stress in Cancer Patients – Revised (QSCP-R23); and the Rotterdam Symptom Checklist (RSCL) (see also Luckett et al.23 and Mitchell24). For each instrument we have reported the number of items, the investigated dimensions, and the reply modality in Table 1. We also reported Vodermaier et al.’s7 evaluations based on the tested psychometric properties in oncological settings and the relative number of studies. Some of these instruments assess psychological distress as an overall construct, some are multidimensional tools that determine the components that comprise psychological distress, other are monofactorial scales relative to 1 of the 2 constructs that usually “saturate” the concept of psychological distress (i.e. anxiety and depression). Except for PDI, HQ-9 and QSCP-R23 (the first developed in Italy, the second and third in Germany), most instruments were developed in Englishspeaking countries: their applicability to different linguistic and cultural contexts, for instance, Italy, cannot be taken for granted25-27. Guillemin et al.25 warn against the risk of a basic questionnaire translation and accurately describe the steps to be followed in providing a version in a different language (translation/back-translation steps) and of adaptation (to obtain a version corresponding to the original text on a semantic, idiomatic, experiential and conceptual level). Hahn et al.26, instead, focus on the importance of psychometric equivalence, which requires the different language versions to be submitted to the same psychometric checks (i.e. validity, reliability) as the original instruments (see also Kazdin27). The aim of the present work was to identify and summarize the validation studies for the Italian versions of the 16 psychological distress screening instruments used most and validated internationally (Table 1). More in detail, we will describe the Italian studies found in the international database on the 16 recommended tools if

B MUZZATTI, MA ANNUNZIATA

they provided validation data. In more operational terms, with the present work we would like to present a guide for Italian clinicians and researchers working in oncology, so that clinicians may choose the screening tool also in the light of the properties of the relative Italian versions and researchers may better identify the instruments that require further investigation for a profitable use in the Italian context. Methods Data sources and searches Vodermaier et al.7 narrow down to 16 the number of instruments recommended for screening psychological distress in oncology (Table 1). We conducted our research on these 16 selected tools in 3 consecutive steps. 1. Interrogation of the MEDLINE and PsycINFO databases. In MEDLINE we conducted 16 different bibliographical searches, each cross-referencing the name/acronym of one of the tools and the term Ital and/or the language of the original paper. In PsycINFO, too, we did 16 different searches using the name or the acronym of each tool for the search string and limiting the research to Italian populations. Both in MEDLINE and PsycINFO the temporal range selected was from the publication year of each original instrument (Table 1) to June 30, 2011. 2. Bibliographic record selection. Once we had obtained the search outputs and read the abstracts, we selected the papers that described the psychometric properties (validity, reliability) related to the use of the Italian samples of the 16 selected tools. 3. References consultation. In order not to overlook any further research, we examined the references of the papers identified in step 2, to find other studies on the validation of one of the 16 instruments for the Italian context. In selecting the papers we have deliberately disregarded studies on psychiatric populations. Data extraction We classified the identified papers according to the instrument they referred to. For each paper, we identified the population involved (healthy vs clinical), the type of validity (criterion, construct, concurrent, divergent, discriminant, cross-cultural) and the type of verified reliability (internal consistency, temporal stability). Results Database interrogation produced 879 results: only 26 were consistent with the aim of the research. Two additional references acquired by the consultation of the bibliographies of the selected articles could be added. Thus, we identified a total of 28 papers meeting the research


PSYCHOLOGICAL DISTRESS SCREENING IN ITALIAN CANCER PATIENTS

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Table 1 - Screening tools recommended by the international literature for detecting psychological distress in oncology Tool

Author

Publication year

Number of items

Response options

Recall period

BDI

Beck et al.8

1961

21

5 possible options

Past week

Depression

4

5

BSI-18

Derogatis9

2000

18

5-point scale

Past week

Clinically relevant psychological symptoms (anxiety, depression, somatization)

4

4

CES-D

Radloff10

1977

20

4-point scale

Past week

Depression

4

5

Akechi et al.11

2006

2

Dichotomous items

The present Depressive disorders

3

5

Chochinov et al.12

1997

1

Dichotomous item

The present Depression

6

4

DT+PC

Roth et al.13

1998

1+36

11-point scale + 36 dichotomous items

Past week

General emotional distress + problems (practical, family, physical, emotional, spiritual)

15

2

EPDS

Cox et al.14

1987

10

4-point scale

Past week

Depressive symptoms

4

4

GHQ-12

Goldberg15

1972

12

4-point or dichotomous scale

Past few weeks

Psychological disorders in general medical settings

2

4

GHQ-28

Goldberg15

1972

28

4-point scale

Past few weeks

Psychological disorders in general medical settings: somatic symptoms, anxiety/insomnia, social dysfunction, severe depression

2

5

HADS

Zigmond & Snaith16

1983

14

4-point scale

Past week

Psychological distress/Anxiety and depressive symptoms in medical settings

41

4

HQ-9

Strittmatter17

1997

9

6-point scale

Past week

Psychosocial distress

1

4

PCL-C

Weathers & Ford18

1996

17

5-point scale

Past month

Post-traumatic stress disorder symptomatology (reexperiencing symptoms, avoidance symptoms, hyperarousal symptoms) in civilian living

3

4

Morasso et al.19

1996

13

5-point scale

Past week

Psychological distress

2

4

Linden et al.20

2005

21

Mixed

Mixed

Depressive symptoms, anxiety symptoms, quality of life (overall), quality of life (number of impaired days), perceived social support, desired social support

2

4

Herschbach et al.21

2003

23

6-point scale

2

4

de Haes et al.22

1990

30+8+1

4-point scale

8

4

Combination Depression Questions Depression Question

PDI PSSCAN

QSCP-R23

RSCL

Dimensions

The present Psychosomatic complaints, fears, information deficits, everyday life restrictions, social strains Past week

Psychological and physical distress + daily activities and 1 item on today’s quality of life

Number of Overall validation judgment studies in (reliability, oncology7 type of criterion measure, validity; 5 levels)7

BDI, Beck Depression Inventory; BSI-18, Brief Symptom Inventory 18; CES-D, Center for Epidemiologic Studies Depression Scale; DT+PC, Distress Thermometer and Problem Checklist; EPDS, Edinburgh Postnatal Depression Scale; GHQ-12, General Health Questionnaire 12; GHQ-28, General Health Questionnaire 28; HADS, Hospital Anxiety and Depression Scale; HQ-9, Hornheide Questionnaire, Short Form; PCL-C, Post Traumatic Stress Disorder Checklist, Civilian version; PDI, Psychological Distress Inventory; PSSCAN, Psychosocial Screen for Cancer; QSCP-R23, Questionnaire on Stress in Cancer Patients – Revised; RSCL, Rotterdam Symptom Checklist.


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requirements, from which we obtained 29 validation studies (as one of the papers provided information on both DT and HADS). Three papers dealt with BDI-II28-30, 3 with CES-D31-33, 3 with DT34-36, 2 with EPDS37,38, 8 with GHQ-1239-46, 7 with HADS35,47-52 (3 of which were limited to the depression subscale50-52), 1 with PDI19, and 2 with RSCL53,54; we did not find any papers on BSI-18, Combination Depression Questions, Depression Question, GHQ-28, HQ-9, PCL-C, PSSCAN or QSCP-R23. In Table 2 we summarize the characteristics of the sample used in each identified study together with information on the estimated validity and reliability. Beck Depression Inventory, version II According to the DSM-IV criteria, BDI-II55 is a partially revised update of BDI, maintaining the same item number and response modality. We identified 3 studies on BDI-II, all of which conducted on the general population or on depressed subjects. These studies reported substantially stable construct validity (consisting in 2 correlated factors summarized in a higher-level factor) and good reliability. Nevertheless, even if data on the concurrent and divergent validity are reported, we do not have any information on the criterion validity, and cutoffs that allow to distinguish between cases and noncases (discriminant validity) were lacking. Center for Epidemiologic Studies Depression Scale We found 3 studies on CES-D. They involved small subsamples from different general medicine units and included neurological, oncological, cardiopathic, orthopedic and depressed patients. Criterion validity was verified only for the neurological and orthopedic subsamples; discriminant validity was reported only in 1 study and was based on score distribution. All 3 studies tested the concurrent validity, while none tested the divergent nor the construct validity. No data on reliability are available for CES-D in Italy. Distress Thermometer The three identified studies on DT all related to cancer patients. They verified the discriminant validity (the suggested cutoffs are dissimilar, as different gold standards were employed) and the concurrent validity. No data on criterion validity, divergent validity and reliability (in particular temporal stability) were reported. Finally, none of the identified studies investigated PC, although this tool is generally coupled with DT. Edinburgh Postnatal Depression Scale The two studies on EPDS had both been conducted on small sample groups of new moms, and both reported data only on criterion and discriminant validity. The reliability data were good, even though, like the data on validity, they were based on a small sample size.


General Health Questionnaire 12 Eight of the identified studies dealt with the GHQ-12 and involved both the general population and patients (i.e. primary care and dermatological patients). Data on criterion and concurrent validity were supplied. The data on the construct and discriminant validity were not concordant: this might be explained by the different scoring methods of the questionnaire (4-point Likert scale versus dichotomous scale). Data on the cross-cultural validity of GHQ-12 were also provided. Five studies rated its reliability as good. Hospital Anxiety and Depression Scale Seven validation studies of HADS were identified: 3 were limited to the depression subscale (HADS-D). Five studies (2 out of 3 on HADS-D) were conducted in cancer patients. For the whole instrument, construct validity data were available (defined as bi- or tri-factorial), as well as criterion and discriminant validity data. Differently from what the construct validity data suggested, the criterion and discriminant validity data concerned the scale taken as an overall indicator (monofactorial scale). Only 1 study on the entire scale provided reliability data that indicated good internal consistency. As regards the D subscale, the identified studies provided information limited to concurrent and discriminant validity, though this was obtained with a small sample size. Psychological Distress Inventory The only identified validation study of PDI concerned Italian cancer patients. In this study, criterion, concurrent and discriminant – but not construct – validity were reported, together with good internal consistency. Rotterdam Symptom Checklist Finally, for the Italian context 2 validation studies of RSCL were identified. One was conducted on a small sample of patients with advanced cancer. Construct and concurrent validity were assessed along with reliability, which showed good internal consistency.

Discussion The utility of monitoring the psychological state of cancer patients along the whole disease course is well established but not always put into practice in the clinical routine56,57. The reasons for the poor monitoring include a lack of time, of familiarity with the instruments, and of dedicated or specialized personnel who could take care of patients who might be identified as “cases”. Given the short time needed to fill in the questionnaire and the little effort required from patients, psychological distress screening is an effective first-level screening



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Table 2 - Psychometric properties of the Italian versions of the recommended tools for screening psychological distress in oncology Tool

Authors

Number and type of the enrolled sample

Validity

Reliability

BDI-II

Montano & Flebus28

574 healthy persons

Construct: by EFA (PAF with promax ro- Internal consistency: 0.86, 0.65 tation) and CFA: 2 correlated factors (cognitive-affective, somatic)

BDI-II

Ghisi et al.29

723 college students + 354 healthy Construct: 2 correlated factors (cogni- Internal consistency: >0.80; adults + 135 depressed subjects tive-affective and somatic in healthy sub- Temporal stability (after 1 month): paired with 135 control subjects jects; cognitive and affective-somatic in 0.76 the clinical sample); Concurrent: with CES-D; Divergent: with BAI, STAI

BDI-II

Sica & Ghisi30

723 college students, 72 depressed Construct: by CFA (2 correlated factors: Internal consistency: 0.80; patients cognitive-affective, somatic) and second- Temporal stability (after 1 month): order PAF (1 second-order factor); Con- 0.76 current: with DQ

CES-D

Pierfederici et al.31

40 depressives and 40 normals who were matched; 325 inpatients of a general hospital; 50 hypertensive patients; 80 gastrointestinal patients; 40 cancer survivors with a previous diagnosis of Hodgkin’s disease; 50 inpatients of a general hospital

CES-D

Fava32

40 depressives and 40 normals who Concurrent: with HDRS were matched

/

CES-D

Caracciolo & Giaquinto33

101 orthopedic and 50 neurological Criterion (against DSM-IV SCID): current inpatients of a rehabilitation center major depressive disorder: sensitivity = 100% in both groups; specificity = 57% in orthopedic patients and 36% in neurological patients; PPV = 24% in orthopedic patients and 31% in neurological patients; NPV = 100% in both samples. Broader range of depressive disorders (dysthymic disorder, adjustment disorders with depressed or mixed mood, minor depressive disorder): sensitivity = 89% and 96%; specificity = 75% and 57%; PPV = 68% and 72%; NPV = 92% and 93%; Concurrent: with HDRS

/

DT

Bulli et al.34

290 patients attending a cancer re- Concurrent: with PDI; Discriminant habilitation center (against PDI): cutoff = 7: sensitivity = 73%; specificity = 82%; PPV = 69%; NPV = 85%

/

DT

Grassi et al.35

109 cancer outpatients

Concurrent: with HADS; Discriminant (against ICD-10 CIDI): for affective disorders (anxiety, adjustment disorders), cutoff = 4: sensitivity = 79.5%; specificity = 75.4%; PPV = 68.6%; NPV = 84.5%; For more severe affective syndromes (major depression, persistent depressive disorders) cutoff = 5: sensitivity = 78.6%; specificity = 83.1%; PPV = 50%; NPV = 95%

/

DT

Grassi et al.36

1108 cancer outpatients

Concurrent: with HADS, BSI-18; Discriminant: cutoff = 4.5 maximizes sensitivity and specificity

/

EPDS

Carpiniello et al.37

61 post-partum women (aged 22-43 years)

Criterion: with Present State Examination; Discriminant: cutoff = 9/10: sensitivity = 100%; specificity = 83%; PPV = 50%; NPV = 100%

/

EPDS

Benvenuti et al.38

113 women between 8th-12th week after delivery

Criterion (against DSM-III.r Mini Interview): Internal consistency: 0.789; cutoff = 8/9: sensitivity = 94.4%; specificity split-half: 0.819 = 87.4% PPV = 58.6%; Discriminant: cutoff = 11/12: sensitivity = 75%; specificity = 67%

Concurrent: with HDRS, MMPI; Discriminant (based on score distribution): cutoff = 23 and 28 identifies caseness for nonhospitalized and hospitalized subjects, respectively

/

Continued


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(Continued) Table 2 - Psychometric properties of the Italian versions of the recommended tools for screening psychological distress in oncology Tool

Authors

GHQ12

Fraccaroli et al.39

GHQ12


Validity

Reliability

416 unemployed young people (17-24 year old)

Construct: by CFA (1 factor if scoring is based on dichotomous items; 3 correlated factors [social functioning, psychophysical symptoms, self-esteem] if scoring is based on Likert scores)

Internal consistency: >0.82 for both scoring methods (dichotomous, Likert); split-half: >0.83 for both scoring methods

Fraccaroli & Schadee40

416 unemployed young people (17-24 year old) and 354 unemployed young British people (18-29 years old)

Construct: by CFA (1 factor if scoring is based on dichotomous items; 3 correlated factors [social functioning, psychophysical symptoms, self-esteem] if scoring is based on Likert scores); Crosscultural: by Multisample CFA: with Great Britain

Internal consistency: >0.82 for both scoring methods (dichotomous, Likert); split-half (even/odd items): >0.72 for both scoring methods

GHQ12

Piccinelli et al.41

94 primary care patients

Criterion: against CIS; Discriminant: for Temporal stability (within 1-2 conventional scoring, cutoff = 3/4: sensi- weeks): >0.81 tivity = 75%, specificity = 74%, PPV = 50%; NPV = 90%; for Likert scoring, cutoff = 13/14: sensitivity = 71%; specificity = 76%; PPV = 50%; NPV = 88%

GHQ12

Politi et al.42 320 18-year old men

Criterion: against psychiatric interview ac- Internal consistency: 0.81 cording to ICD-9 criteria; Construct: by EFA (PCA, oblimin rotation): 2 factors (general dysphoria, social dysfunction); Concurrent: MMPI (subscales: depression, conversion hysteria, psychasthenia); Discriminant: cutoff = 8/9: sensitivity = 68%, specificity = 59%; PPV = 19%; NPV = 93%

GHQ12

Picardi et al.43

2579 dermatological patients

Construct: by EFA (PAF with direct quar- Internal consistency: 0.88; Tempotimin rotation): both 2 (social dysfunc- ral stability (within 1 week): 0.72 tion, general dysphoria) and 3 (social dysfunction, anxiety, loss of self-esteem) factors; Concurrent: with Skindex-29; Discriminant: Comparing scores of 2 different clinical subgroups (patients with inflammatory skin diseases vs patients with isolated skin lesions)

GHQ12

Claes & Fraccaroli44

232 employed persons

Construct: by CFA: 3 correlated factor (general dysphoria, social dysfunction, loss of confidence); Cross-cultural: by Multisample CFA: with Belgium, UK, Netherlands, Portugal, Spain

/

GHQ12

Picardi et al.45

521 dermatological inpatients

Criterion (against DSM-IV SCID-I); Discriminant: for psychiatric disorders: cutoff = 3/4: sensitivity = 68%, specificity = 64%, PPV = 53%, NPV = 77%

/

GHQ12

Picardi et al.46

141 dermatological inpatients

Criterion (against DSM-IV SCID-I): for major depressive disorder, sensitivity = 73%; specificity = 78%; PPV = 22%; NPV = 97%. For dysthymic disorders, sensitivity = 56%; specificity = 76%; PPV = 14%; NPV = 96%; Discriminant: cutoff = 7+ for major depressive disorder, cutoff = 6/7 for dysthymic disorder

/

HADS

Costantini et al.47

197 breast cancer patients tested before the start of chemotherapy (T1) and at the first follow-up visit (T2)

Criterion: against DSM-III.r SCID; Construct: Internal consistency: >0.80 in total by EFA (oblimin rotation): 2 correlated fac- scale and both subscales tors at T1 and 3 correlated factors at T2; Discriminant: cutoff = 10 (total scale): sensitivity = 84%; specificity = 79%; PPV = 71%

HADS

Fossati & Marzocchi48

100 + 100 cardiological inpatients

Construct: by EFA (PAF with promax rotation) and CFA: 2 factors and 2-3 factors, respectively

/

Continued



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(Continued) Table 2 - Psychometric properties of the Italian versions of the recommended tools for screening psychological distress in oncology Tool

Authors


Validity

Reliability

HADS

Grassi et al.35 109 cancer outpatients

Discriminant (against ICD-10 CIDI): for affective disorders (anxiety and adjustment disorders) cutoff = 10 (total scale): sensitivity = 86%; specificity = 81.5%; PPV = 76%; NPV = 89.9%. For more severe affective syndromes (major depression, persistent depressive disorders) cutoff = 15 (total scale): sensitivity = 85%; specificity = 96%; PPV = 80%; NPV = 97%

/

HADS

Annunziata et al.49

512 hospitalized cancer patients

Construct: CFA: 2-factor model invariant across gender and disease phase (diagnostic, therapeutic)

/

HADS Subscale D

Mondolo et al.50

46 non-demented Parkinson’s dis- Concurrent: with HDRS; Discriminant: ease patients cutoff = 10/11: sensitivity = 100%; specificity = 95%; PPV = 71%; NPV = 100%

/

HADS Subscale D

Castelli et al.51

53 patients newly diagnosed with Concurrent: with Montgomery-Asberg lung cancer Depression Rating Scale (higher agreement for cutoff = 8 than cutoff = 11)

/

HADS Subscale D

Castelli et al.52

151 cancer patients

Concurrent: with Montgomery-Asberg Depression Rating Scale (higher agreement for cutoff = 8 than cutoff = 11)

/

PDI

Morasso et al.19

102 + 107 + 225 cancer patients

Criterion: against ICD-X criteria; Concur- Internal consistency: 0.88 rent: with STAI, EPQ; Discriminant: cutoff = 29: sensitivity = 75%; specificity = 85%

RSCL

Paci53

147 healthy women

Construct: by EFA (varimax rotation): 2 Internal consistency: 0.91; 0.87 factors (psychological, physical); Concurrent: with STAI and an item on general well-being

RSCL

Ravaioli et al.54

60 patients with advanced cancer

Discriminant: comparing scores of pa- Internal consistency: 0.76 for the tients at different chemotherapy cycles psychological, 0.85 for the physical scale

BDI-II, Beck Depression Inventory, version II; CES-D, Center for Epidemiologic Studies Depression Scale; DT+PC, Distress Thermometer and Problem Checklist; EPDS, Edinburgh Postnatal Depression Scale; GHQ-12, General Health Questionnaire 12; HADS, Hospital Anxiety and Depression Scale; PDI, Psychological Distress Inventory; RSCL, Rotterdam Symptom Checklist; DQ, Depression Questionnaire; BAI, Beck Anxiety Inventory; STAI, State Trait Anxiety Inventory; HDRS, Hamilton Rating Scale for Depression; MMPI, Minnesota Multiphasic Personality Inventory; EPQ, Eysenck Personality Questionnaire; DSM-IV, Diagnostic Statistic Manual, Version IV; DSM-III.r, Diagnostic Statistic Manual, Version III revised; SCID, Semi-structured Clinical Interview for DSM; CIDI, Composite International Diagnostic Interview; CIS, Clinical Interview Schedule; Scann2, World Health Organization Scann, Version 2; EFA, exploratory factor analysis; CFA, confirmative factor analysis; PAF, principal axis factoring; PCA, principal component analysis; PPV, positive predictive value; NPV, negative predictive value; ICD-X, Classification of Mental and Behavioural Disorders, X.

that can roughly identify the most psychologically vulnerable subjects, that is, patients who deserve more accurate assessment (requiring more time and specifically trained psychological or psychiatric personnel) and individual consultation. With the present work we would like to give an overview of the validation studies of psychological distress screening tools in the Italian context to identify those that are more adequately applicable to a cancer setting. We started from the accurate review by Vodermaier et al.7, which narrowed the number of predominantly used valid and reliable instruments to 16, and later consulted the MEDLINE and PsycINFO databases to find all validation studies that had been conducted in

Italy. We thus obtained data on 8 of the 16 tools. Of these 8 tools, 5 assess psychological distress (DT, GHQ-12, HADS, PDI, RSCL), while 3 address only 1 of its components, namely a depressive state (BDI-II, CES-D, EPDS). Of the 5 tools to assess psychological distress, the most investigated is GHQ-12, even though a univocal evaluation of its construct and discriminant validity is not available: this limits the reliability data and the interpretation of other validity aspects. If an instrument is multifactorial, it could be useful to extend both reliability and validity assessment to its subscales. However, if the instrument is considered a psychological distress measure (cf. the definition proposed in the introduction), verifying its criterion validity only for depressive disorders


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may be limitative. The same considerations can be made for HADS. Also for DT, it is difficult to determine the discriminant validity unequivocally. Nonetheless, for this tool a multicenter validation study is being drafted, of which the paper by Grassi et al.36 is a preliminary report. As already mentioned, there are no validation data on PC, which is usually associated with DT. We found no criterion and discriminant validity data for RSCL. Finally, even though there is only 1 study on PDI, it provides encouraging, albeit incomplete, information on reliability and validity but no data on construct validity. As regards the 3 assessment tools for depression, the main limitations are the small number of participants used for verifying CES-D and EPSD, and the lack of data on criterion and discriminant validity in BDI-II (partial in CES-D and EPDS). Among the 8 instruments reckoned to be “promising” (for which no validation studies have yet been conducted in Italy), unpredictably, we found some tools that have a well time-proven position on the international scene, like the BSI-18 and the GHQ-28. In conclusion, we may assume that none of the 16 psychological distress screening tools have undergone a complete and organic validation process for Italy, especially in an oncological context. The partial data available are encouraging, but for an informed use of the tools we would have to investigate all the main types of validity considered (criterion, construct, concurrent, divergent and discriminant validity) as well as reliability, with particular attention to internal consistency. Administering a battery of questionnaires relative to similar constructs (or to the same construct) and a clinical structured interview is often difficult in oncology. This is due to the numerous and debilitating effects of the disease and its treatments on patients. It can also be expensive and time-consuming for the personnel employed in this task, but still remains the only method to be sure that what we are measuring is exactly what we need to measure. Having conducted the search through databases may constitute a limitation to the present work: this type of investigation will exclude papers published and distributed at a local level or by professional associations, which are numerous but have a poor distribution. The strong point of this work is that it has systematized the resources available on this issue, thus offering a good starting point to researchers interested in adapting adequate psychometric tools, and a warning for those operators who, often with the best intentions, deem sufficient a good translation of questionnaires, thus ignoring the importance of psychometric assessments needed before the obtained data can be used. References 1. National Comprehensive Cancer Network: Distress management. Clinical practice guidelines. J Natl Compr Canc Netw, 1: 344-374, 2003.


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