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Contents lists available at ScienceDirect

Schizophrenia Research
j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / s c h r e s

The Schizophrenia Caregiver Quality of Life questionnaire (S-CGQoL): Development and validation of an instrument to measure quality of life of caregivers of individuals with schizophrenia
R. Richieri a, L. Boyer b,, G. Reine c, A. Loundou d, P. Auquier e, C. Lanon a,e, M.C. Simeoni e
a b c d e

Department of Psychiatry, Sainte-Marguerite University Hospital, Assistance Publique-Hpitaux de Marseille, 13009 Marseille, France Department of Public Health, La Timone University Hospital, Assistance Publique-Hpitaux de Marseille, 13005 Marseille, France Department of Psychiatry, Toulon-La Seyne Hospital, 83000 Toulon, France Department of Clinical Research, University Hospital, Assistance Publique-Hpitaux de Marseille, 13005 Marseille, France Department of Public Health, EA 3279 Research Unit, University Hospital, Assistance Publique-Hpitaux de Marseille, 13005 Marseille, France

a r t i c l e

i n f o

a b s t r a c t
Objective: This study aims to validate a self-administered, multidimensional QoL instrument based on the point of view of caregivers of individuals with schizophrenia. Methods: Data were collected through the departments of six psychiatric hospitals in France (n = 246). The item reduction and validation processes were based on both item response theory and classical test theory. Results: The S-CGQoL contains 25 items describing seven dimensions (Psychological and Physical Well-Being; Psychological Burden and Daily Life; Relationships with Spouse; Relationships with Psychiatric Team; Relationships with Family; Relationships with Friends; and Material Burden). The seven-factor structure accounted for 74.4% of the total variance. Internal consistency was satisfactory; Cronbach's alpha coefcients ranged from 0.79 to 0.92 in the whole sample. The scalability was satisfactory, with INFIT statistics falling within an acceptable range. In addition, the results conrmed the absence of DIF and supported the invariance of the item calibrations. Conclusion: The S-CGQoL is a self-administered QoL instrument that presents satisfactory psychometric properties and can be completed in 5 min, thereby fullling the goal of brevity sought in research and clinical practice. 2010 Elsevier B.V. All rights reserved.

Article history: Received 25 May 2010 Received in revised form 24 August 2010 Accepted 25 August 2010 Available online xxxx Keywords: Quality of life Schizophrenia Caregiver Questionnaire Validation

1. Introduction Schizophrenia is a disabling and severe psychiatric disorder with either episodic or continuous evolution that can result in physical, psychological and social problems related to both the disease and the potential side effects of its treatment (Green et al., 2000; Kasckow et al., 2001; Kurtz et al., 2008; Lehman, 1983; Reine et al., 2005). Schizophrenia also affects the

Corresponding author. Department of Public Health, La Timone University Hospital, 264 Rue Saint Pierre, 13855 Marseille cedex 05, France. Tel.: +33 686936276; fax: +33 491433516. E-mail address: laurent.boyer@ap-hm.fr (L. Boyer). 0920-9964/$ see front matter 2010 Elsevier B.V. All rights reserved. doi:10.1016/j.schres.2010.08.037

functioning of family caregivers, especially because the caregivers have assumed functions that were performed in the past by psychiatric institutions (Caqueo-Urizar et al., 2009; Ochoa et al., 2008; Reine et al., 2003b). The impact of caregiving on caregivers' quality of life (QoL) is important (Caqueo-Urizar et al., 2009; Martens and Addington, 2001). Caregivers of individuals with schizophrenia have reported reduced QoL, especially when experiencing a signicant burden (Glozman, 2004; Li et al., 2007), restricted roles and activities, and increased psychosomatic, anxious, or depressive symptoms (Awad and Voruganti, 2008; Schulz and Beach, 1999). Caregivers' negative experience may affect their ability to care for the patients. This is an important concern because

Please cite this article as: Richieri, R., et al., The Schizophrenia Caregiver Quality of Life questionnaire (S-CGQoL): Development and validation of an instrument..., Schizophr. Res. (2010), doi:10.1016/j.schres.2010.08.037

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involvement of family caregivers is essential for optimal treatment of patients by ensuring treatment compliance, continuity of care, and social support (Reine et al., 2003b; Velligan et al., 2009). Several studies have shown that a lack of family involvement in treatment planning is associated with problems in treatment adherence (Ahn et al., 2008; Cooper et al., 2007; Valenstein et al., 2004). Therefore, assessing and preserving caregivers' QoL is a noteworthy issue both for the caregivers themselves and indirectly for patients' health. Caregivers of individuals with schizophrenia have received signicant attention in the past few years. Most of the research is focused on caregivers' burden (Levene et al., 1996; Provencher and Mueser, 1997; Schene et al., 1994), caregiving (Joyce et al., 2000; Szmukler et al., 1996), coping strategies (Magliano et al., 1996; Roncone et al., 2007; Rosen et al., 1989, 2001) and opinions on the causes and consequences of mental disorders (Kallert and Nitsche, 2008; Magliano et al., 1999). Although studies have been conducted on specic issues in caregiving, little has been done to explore QoL among caregivers of individuals with schizophrenia, and no QoL measurement scale has been specically developed for use with this population (Caqueo-Urizar et al., 2009; Li et al., 2007; Martens and Addington, 2001). A self-administered instrument based on the caregivers' point of view and anchored in an explicit conceptual approach (McKenna, 1997) could constitute an innovative area of research in schizophrenia. An exploration and evaluation of the caregivers' QoL could be useful in improving patients' health and QoL, preserving caregivers' health and their ability to care, and developing new care strategies. We present the results of the development and the validation of a self-administered, multidimensional QoL instrument based on the point of view of caregivers of individuals with schizophrenia: the Schizophrenia Caregiver Quality of Life questionnaire (S-CGQoL). 2. Methods

mother or a father, we asked the patient if we could contact the caregiver. When the patient agreed and when the caregiver met the inclusion criteria, the following information was collected via self-report questionnaires (completed by the caregivers) or routine clinical interview (conducted with the patient by a psychiatrist). 2.3. Data collection The data collected included the following: 1. Socio-demographic characteristics of the caregivers: gender, age, number of children, and employment status. 2. Socio-demographic and clinical characteristics of the individuals with schizophrenia: age at the onset of the disease; type of schizophrenia, according to DSM-IV; psychotic symptoms, based on the Positive and Negative Syndrome Scale (PANSS), which contains ve subscales: positive symptoms, negative symptoms, disorganization symptoms, excitement, and emotional distress (Kay et al., 1986; van der Gaag et al., 2006a,b). 3. QoL questionnaires: The self-administered survey materials that were completed by the caregivers included the tested QoL questionnaire (S-CGQoL), and a validated generic QoL questionnaire: the Short Form 36 (SF-36) (Leplege et al., 1998; Ware and Sherbourne, 1992), which is one of the most widely used generic quality of life scales for caregivers of individuals with schizophrenia. SF-36 is a generic, self-administered QoL questionnaire, consisting of 36 items describing 8 dimensions: Physical Functioning (PF), Social Functioning (SF), Role-Physical Problems (RPP), Role-Emotional Problems (REP), Mental Health (MH), Vitality (VIT), Bodily Pain (BP), and General Health (GH). Each dimension is scored within a range of 0 (low QoL level) to 100 (high QoL level). 2.4. Questionnaire development

2.1. Subjects Data were collected from the departments of six psychiatric hospitals in France: Ajaccio (one hospital), Bordeaux (one), La Seyne sur Mer (one), Marseille (two), and Paris (one). The inclusion criteria for the caregiver were as follows: (1) having a family member with a diagnosis of schizophrenia or schizoaffective disorder, according to the DSM-IV criteria (APA, 1994); (2) being the mother or the father of the patient; (3) being identied by the individual with schizophrenia as the main caregiver; (4) being 18 years of age or older; (5) giving informed consent to participate in the study and (6) being a native French speaker. This project was conducted in accordance with the Declaration of Helsinki and French Good Clinical Practices (CNIL, 2004; WMA, 2008). 2.2. Procedure For a period of one month, personnel from each center identied inpatients and outpatients who had been given a diagnosis of schizophrenia and were between 18 and 64 years old. Each patient was asked by a medical or nursing staff to name his or her main caregiver. When the patient identied a The development of the S-CGQoL occurred in two phases: qualitative and quantitative. Item generation occurred during the qualitative phase, and item reduction and the validation process (Crocker and Algina, 1986) occurred during the quantitative phase. The two phases were conducted with different samples. 2.4.1. Item generation: a qualitative approach Item generation occurred in two steps. First, the content of the questionnaire was derived from face-to-face, semi-structured interviews performed by a trained interviewer (Juniper et al., 1996). The interviews have been described elsewhere (Lanon et al., 2000; Reine et al., 2003b). Briey, interviews addressed the impact of the disease on caregivers' QoL, based on the theory of expectation, which denes quality of life as the discrepancy between expectations and current life experience (Calman, 1988). Caregivers' interviews were also used to determine the wording in question stems and the range of response options. Interviews were conducted until no new ideas emerged in the content analysis performed in real time, up to a total of 33 (Reine et al., 2003b). Interviews were recorded and entirely

Please cite this article as: Richieri, R., et al., The Schizophrenia Caregiver Quality of Life questionnaire (S-CGQoL): Development and validation of an instrument..., Schizophr. Res. (2010), doi:10.1016/j.schres.2010.08.037

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transcribed. Content analysis was performed by three members of the steering committee who were skilled in textual analysis and complemented by a computerised textual analysis (Alceste software) (Kaid and Wadsworth, 1989). Sixty-six questions were identied from these interviews. These items were answered using a six-point Likert scale, dened as 1Never/Not at all, 2Rarely/A little, 3Sometimes/ Somewhat, 4Often/A lot, 5Always/Very much and 6 Not applicable. Second, 20 caregivers and 20 members of the French National Union of Friends and Families of Mentally Ill Persons (UNAFAM) were asked to comment on any aspect of the questionnaire (i.e., content, wording, response choices) that they felt was irrelevant or merited improvement. Items that were ambiguous, misunderstood or rarely answered were withheld or reworded, leading to a preliminary questionnaire that comprised 59 items. Finally, the initial interviews with the caregivers guaranteed that the questionnaire was a true reection of the caregivers' experience and consequently ensured content validity. The second round of interviews with caregivers and members of UNAFAM ensured face validity. 2.4.2. Item reduction and validation of the S-CGQoL: a quantitative approach The item reduction process took into account both the results of statistical analyses and the expertise of the steering committee. Statistical approaches were based on both item response theory (van der Linden and Hambleton, 1997) and classical test theory. Removal of the items was discussed with regard to both metrological properties and impact on the nal instrument's content, taking into account the items' meanings. The more meaningful and psychometrically sound solution was kept to produce the nal version of the S-CGQoL questionnaire. The nal version of the S-CGQoL was then tested for construct validity, reliability, and some aspects of external validity. Floor and ceiling effects were reported to assess the skewness of the response distribution. The oor effect refers to the proportion of individuals who have the worst possible QoL score, and the ceiling effect refers to the proportion with the best score possible. A high oor or ceiling effect limits the value of a tool because individuals falling within the highest and lowest ranges cannot receive better or worse scores than they have presently. Consequently, it causes a relative lack of sensitivity in the questionnaire. Construct validity denes the construct to be measured by the instrument and assesses the internal structure of its components and the theoretical relationship of its item and subscale scores. It was assessed using principal component factor analyses with varimax rotation (Nunnaly and Bernstein, 1994) in order to determine the nal structure and the number of independent dimensions. Eigenvalues greater than or equal to 1 were retained (Kaiser and Caffrey, 1965). Items were kept in their respective dimensions if they revealed loadings greater than 0.4. The unidimensionality of each dimension was assessed using Rasch analyses (van der Linden and Hambleton, 1997). The partial credit model, an extension of the Rasch model for Likert-type responses, was used. The scalability of each of the dimension scales was assessed by the pattern of

item goodness-of-t statistics (INFIT); a value of INFIT between 0.7 and 1.2 ensures that all items of the scale tend to measure the same concept (Wright and Stone, 1979). Differential item functioning (DIF) analyses were performed to check whether all items behaved in the same way among subgroups dened according to potential confounding factors: age (N= or b60 years) and gender. A Rasch rating scale model was used to identify invariance of item calibrations (a form of DIF) (Zumbo, 1999). In addition, inter-dimension correlations were examined using Pearson's and polychoric coefcients. Item internal consistency was assessed by correlating each item with its scale (corrected for overlap) using Pearson's coefcient (a level of 0.4 is recommended for supporting item-internal consistency (Carey and Seibert, 1993). Item discriminant validity was assessed by determining the extent to which items correlated more highly with the dimensions that they were hypothesised to represent than they did with others (Campbell and Fiske, 1959). Internal consistency reliability refers to the strength of the correlation between items within each domain of the questionnaire and between all items in the questionnaire. It was carried out by calculating the Cronbach's alpha coefcient (a coefcient of at least 0.7 was expected for each dimension) (Cronbach, 1951). External validity was tested by studying the correlations of the S-CGQoL dimension scores with the scores of the SF-36. The underlying assumption was that dimension scores of SCGQoL would be more correlated with scores of similar dimensions from SF-36 than they would be with dissimilar ones. Another aspect of validity was examined using the known-group approach, by testing the associations (comparisons of means or correlations) between the S-CGQoL scores and socio-demographic variables (gender, age, number of children, employment status, and age at the onset of the disease) or clinical features (type of schizophrenia and PANSS). The comparisons of means were performed using Student's t-test or analysis of variance (ANOVA), followed by a Bonferonni post hoc analysis. Several hypotheses were formulated: the S-CGQoL dimension scores (1) should differ according to socio-demographic characteristics of the caregivers: mothers, younger parents and caregivers who lived alone with their child would have lower levels of QoL; (2) QoL should be negatively correlated with the severity of the schizophrenia. Data analyses were performed using SPSS 15.0 and WINSTEP software (Wright et al., 2001). 3. Results Only the results of the nal psychometric validation phase are reported in order to avoid confusion with intermediate development versions of the questionnaire. 3.1. Sample characteristics Of the 347 patients who were screened during the study period, 82 did not identify a mother or a father as the main caregiver (23.6%). Among the 265 patients who identied their mother or father, 19 had caregivers who refused to participate in the study. Therefore, our sample consisted of

Please cite this article as: Richieri, R., et al., The Schizophrenia Caregiver Quality of Life questionnaire (S-CGQoL): Development and validation of an instrument..., Schizophr. Res. (2010), doi:10.1016/j.schres.2010.08.037

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Fig. 1. Caregiver enrollment. The analytical sample consisted of caregivers: (1) having a family member with a diagnosis of schizophrenia or schizoaffective disorder, according to the DSM-IV criteria, (2) being the mother or the father, (3) being identied by the individual with schizophrenia as the main caregiver, (4) being 18 years of age or older, (5) giving informed consent to participate in the study and (6) being a native French speaker.

246 caregivers (70.9%) (Fig. 1). The characteristics of the caregivers and individuals with schizophrenia are presented in Table 1. Of the 246 caregivers, the mean age was 60.6 years (S.D. = 9.5) and 67.1% was mothers. A majority of the caregivers were unemployed (62.6%), and, for 22.8%, one of
Table 1 Sociodemographic and clinical characteristics of caregivers and individuals with schizophrenia (n = 246). n Caregivers Gender (female) Age (years), mean SD Number of children (N 1) Employment status (unemployed) 165 60.6 208 154 % 67.1 9.5 84.6 62.6

the two parents lived alone with their child. 3.2. Scoring For each individual, a score for each of the dimensions was obtained by computing the mean of the item scores on the dimension. If fewer than one half of the items were missing, the mean of non-missing items was substituted for the missing items. All dimension scores were linearly transformed to a 0 to 100 scale, with 100 indicating the best possible level of QoL and 0 the worst. A global QoL index, the S-CGQoL index, was computed as the mean of the individual dimensions. 3.3. Construct validity and reliability (Table 2) The iterative process of item selection resulted in a nal version comprised of 25 items describing seven dimensions (see Appendix A). Each dimension was named according to its constituent items, as follows: PsPhW: Psychological and Physical Well-Being (5 items); PsBDL: Psychological Burden and Daily Life (7 items); RS: Relationships with Spouse (3 items); RPT: Relationships with Psychiatric Team (3 items); RFa: Relationships with Family (2 items); RFr: Relationships with Friends (2 items); and MB: Material Burden (3 items) (Table 2). The seven-factor structure accounted for 74.4% of the total variance. The overall scalability was satisfactory, as all items showed a good t to the Rasch model within each dimension, with no items showing an INFIT statistic outside of the acceptable range, except for Relationships with Spouse. The results also conrmed the absence of DIF according to gender or age and supported the invariance of the item calibrations. Item internal consistency was satisfactory for all dimensions,

Individuals with schizophrenia Age at onset of illness (years), mean SD 21.8 Illness duration 9.8 Living situation (MD = 5) With one parent 55 With two parents 101 Independent 85 PANSS score, mean SD Total PANSS (range from 30 to 210) 71.5 Positive factor 15.9 Negative factor 19.5 Excitement 8.4 Disorganization symptoms 11.3 Emotional distress 7.7 Diagnosis of schizophrenia subtypes and schizoaffective disorder Paranoid 153 Undifferentiated 32 Disorganised 8 Residual 43 Schizoaffective disorder 10 SD: standard deviation. MD: missing data.

6.8 8.6 22.8 41.9 35.3 18.8 6.4 6.9 3.6 4.4 3.6 62.2 13.0 3.3 17.5 4.1

Please cite this article as: Richieri, R., et al., The Schizophrenia Caregiver Quality of Life questionnaire (S-CGQoL): Development and validation of an instrument..., Schizophr. Res. (2010), doi:10.1016/j.schres.2010.08.037

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Table 2 Dimension scale characteristics: item-internal consistency (IIC), item-discriminant validity (IDV), percentage of missing values (%MV), oor effect (Floor), ceiling effect (Ceiling), Cronbach's Alpha (Alpha), Rasch statistics (INFIT), intra-class correlation coefcient (ICC) of the S-CGQoL dimension scores and global index mean (SD) (n = 246). S-CGQoL Mean (SD) IIC Minmax PsPhW PsBDL RS RPT RFa RFr MB Index 53.9 (18.5) 62.8 (16.4) 69.5 (21.9) 63.0 (20.7) 57.9 (22.8) 62.9 (20.7) 69.1 (22.4) 62.7 (11.4) 0.830.92 0.640.78 0.740.91 0.920.95 0.930.94 0.930.94 0.800.88 NA c IDV Minmax 0.010.56 0.000.52 0.000.39 0.000.29 0.000.41 0.060.34 0.070.42 NA c 0.4 0.4 7.7 5.3 4.5 4.9 5.3 19.9 11.7 13.1 7.7 8.1 15.5 8.7 10.2 11.4 7.0 14.9 45.4 10.9 9.8 10.0 31.7 15.3 0.92 0.88 0.80 0.92 0.87 0.85 0.79 0.87 MV (%) Floor (%) Ceiling (%) Alpha a INFIT b Minmax 0.701.20 0.781.18 0.601.30 0.751.13 0.960.98 0.980.99 0.781.19 NA c

S-CGQoLPsPhW: Psychological and Physical Well-being; PsBDL: Psychological Burden and Daily Life; RS: Relationships with Spouse; RPT: Relationships with Psychiatric Team; RFa: Relationships with Family; RFr: Relationships with Friends; MB: Material Burden; Index, global S-CGQoL score. S-CGQoL scores, ranging from 0 to 100 (with 100 indicating best quality of life). a Cronbach's alpha. b Rasch statistics. c Not applicable.

ranging from 0.64 to 0.95 for each item. The correlation of each item with its associated dimension was higher than its correlation with the other dimensions (item discriminant validity). Cronbach's alpha coefcients ranged from 0.79 to 0.92 in the whole sample, indicating high internal consistency. The deletion of any of the 25 items did not increase the internal consistency of any of the 7 dimensions.

3.4. External validity The S-CGQoL index was signicantly correlated with all SF-36 dimension scores (rs = 0.170.42). However, only two dimensions of the S-CGQoL (PsPhW, PsBDL) showed medium to high correlations with dimension scores of the SF-36 assessing mental and physical well-being: PsPhWPF, PsPhWSF, PsPhWRPP, PsPhWMH, PsPhWVIT, PsPhW GH, PsBDLSF, and PsBDLMH. On the contrary, the specic dimensions of the S-CGQoLRelationships with Spouse (RS), with Psychiatric Team (RPT), with Family (RFa), with Friends (RFr), and Material Burden (MB)were globally uncorrelated or weakly correlated with the dimensions of SF-36 (Table 3).

Comparisons by gender (female vs. male) showed signicant differences for two dimensions: PsPhW 51.4 (SD= 17.6) vs. 59.3 (SD = 19.4), p = 0.002; and RS 65.1 (SD = 23.0) vs. 77.7 (SD=17.0), p b 0.0001. A higher number of children were associated with a higher S-CGQoL score for (MB) and the overall index. Unemployed caregivers showed a signicantly higher level of RS and a lower level of RFr. Caregivers who reported that they lived alone with the individual with schizophrenia reported a signicantly lower QoL than those who were part of a couple or for whom the individual with schizophrenia lived independently (RS, RFa and the index). Caregivers of individuals with paranoid schizophrenia reported lower S-CGQoL scores (RPT and index) when compared to caregivers of individuals with a disorganized form of schizophrenia (Table 4). Three S-CGQoL dimension scores (PsBDL, RS and RFr) produced signicant levels of correlation with the age of the caregiver (respectively, 0.20, 0.14 and 0.20). The age of the patient at the onset of the disease was signicantly correlated with three dimensions (PsBDL, RS, RFa) and the index (rs = 0.140.24). Higher QoL levels of caregivers were globally associated with lower levels of severity of schizophrenia. S-CGQoL dimension scores were signicantly and negatively correlated with the PANSS total (PsPhW, RFr, MB

Table 3 Spearman's correlations between S-CGQoL scores and short-form 36 scores (n = 246). PsPhW PF SF RPP REP MH VIT BP GH 0.46 0.53 0.43 0.37 0.70 0.66 0.45 0.52 PsBDL 0.27 0.41 0.28 0.25 0.43 0.37 0.23 0.34 RS 0.14 0.13 0.15 0.06 0.15 0.13 0.10 0.12 RPT 0.11 0.06 0.02 0.07 0.11 0.04 0.04 0.07 RFa 0.18 0.23 0.18 0.08 0.23 0.18 0.06 0.20 RFr 0.13 0.11 0.14 0.06 0.12 0.03 0.18 0.24 MB 0.15 0.07 0.13 0.00 0.09 0.09 0.17 0.29 Index 0.37 0.37 0.33 0.17 0.42 0.32 0.29 0.42

S-CGQoLPsPhW: Psychological and Physical Well-being; PsBDL: Psychological Burden and Daily Life; RS: Relationships with Spouse; RPT: Relationships with Psychiatric Team; RFa: Relationships with Family; RFr: Relationships with Friends; MB: Material Burden; Index, global S-CGQoL score. S-CGQoL scores, ranging from 0 to 100 (with 100 indicating best quality of life). SF-36PF: Physical Functioning; SF: Social Functioning; RPP: RolePhysical Problems; REP: RoleEmotional Problems; MH: Mental Health; VIT: Vitality; BP: Bodily Pain; and GH: General Health. p b 0.05. p b 0.01.

Please cite this article as: Richieri, R., et al., The Schizophrenia Caregiver Quality of Life questionnaire (S-CGQoL): Development and validation of an instrument..., Schizophr. Res. (2010), doi:10.1016/j.schres.2010.08.037

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Table 4 Comparisons of S-CGQoL score means (SD) according to gender, number of children, employment status of the caregiver, and living situation, subtypes of schizophrenia diagnosis (n = 246). PsPhW Gender of caregiver Female Male p value 51.4 (17.6) 59.3 (19.4) 0.002 PsBDL 61.5 (15.8) 65.5 (17.3) 0.074 RS 65.1 (23.0) 77.7 (17.0) b 0.0001 RPT 64.7 (20.1) 59.6 (21.7) 0.079 Rfa 56.5 (23.6) 60.9 (20.9) 0.168 RFr 64.1 (20.6) 60.5 (21.0) 0.224 MB 68.7 (22.8) 70.0 (21.7) 0.680 Index 61.9 (10.9) 64.4 (12.2) 0.147

Number of children of caregiver 1 51.7 (18.5) 2+ 54.4 (18.5) p value 0.429 Employment status of caregiver Employed 54.6 (19.3) Unemployed 53.6 (18.1) p value 0.695

59.1 (19.6) 63.5 (15.7) 0.202

63.5 (21.2) 70.6 (21.9) 0.072

57.4 (21.2) 64.0 (20.5) 0.084

57.3 (21.5) 58.1 (23.0) 0.853

58.9 (21.5) 63.6 (20.6) 0.211

61.7 (18.8) 70.5 (22.8) 0.030

58.3 (9.8) 63.5 (11.5) 0.023

61.6 (16.8) 63.6 (16.2) 0.373

65.0 (22.7) 72.2 (21.1) 0.015

65.5 (20.0) 61.6 (21.1) 0.175

58.2 (22.5) 57.8 (23.0) 0.898

67.4 (20.4) 60.3 (20.5) 0.010

69.8 (22.7) 68.7 (22.3) 0.733

63.4 (11.5) 62.3 (11.3) 0.529

Living situation of the individual with schizophrenia One parent 55.6 (20.4) 62.8 (16.9) Two parents 51.6 (17.1) 61.8 (15.5) Independent 55.8 (19.3) 64.1 (17.6) p value 0.240 0.634

53.6 (25.3) 74.4 (18.2) 71.9 (19.7) b 0.0001

60.8 (23.0) 62.8 (19.4) 64.4 (21.2) 0.631

46.5 (21.3) 63.6 (23.9) 58.9 (19.6) b0.0001

60.6 (21.8) 64.5 (21.1) 62.1 (20.0) 0.510

65.8 (23.7) 68.1 (22.7) 72.6 (20.8) 0.191

58.4 (11.7) 63.5 (12.0) 64.0 (10.3) 0.050

Subtypes of schizophrenia diagnosis and schizoaffective disorder Paranoid 52.3 (18.2) 60.6 (16.8) 68.7 (20.5) Undifferentiated 56.2 (18.5) 65.6 (15.4) 64.4 (24.6) Disorganised 46.5 (7.7) 63.8 (7.9) 83.3 (15.1) Residual 59.7 (20.4) 67.0 (15.6) 72.3 (24.1) Schizoaffective disorder 52.9 (17.5) 69.1 (17.2) 73.0 (27.2) p value 0.132 0.084 0.215

60.5 (20.5) 66.1 (21.8) 80.0 (17.8) 63.2 (19.5) 78.5 (18.5) 0.010

56.0 (22.2) 58.3 (22.7) 77.5 (19.1) 60.5 (22.8) 61.4 (31.8) 0.103

62.4 (21.1) 61.0 (20.8) 70.0 (21.4) 62.6 (20.5) 72.0 (16.2) 0.527

67.0 (23.6) 70.2 (20.4) 82.9 (14.3) 73.0 (19.5) 72.7 (23.2) 0.256

61.0 (10.9) 62.5 (9.7) 74.7 (8.3) 65.6 (12.4) 68.4 (14.8) 0.006

S-CGQoLPsPhW: Psychological and Physical Well-being; PsBDL: Psychological Burden and Daily Life; RS: Relationships with Spouse; RPT: Relationships with Psychiatric Team; RFa: Relationships with Family; RFr: Relationships with Friends; MB: Material Burden; Index, global S-CGQoL score. S-CGQoL scores, ranging from 0 to 100 (with 100 indicating best quality of life). Values signicant at the 5% level are marked in bold.

and Index), positive (RFr and Index), negative (RPT) and emotional distress scores (RS and Index). In contrast, no signicant correlation was found with excitement or disorganization symptom scores of the PANSS (Table 5).

The rate of missing data was globally low: between 0.4 and 7.7% for the dimension scores and 19.9% for the index (Table 2). 4. Discussion

3.5. Acceptability The average completion time is expected to be less than ve minutes, which is fully compatible with clinical practice.

In the past, the primary emphases in research have been on the person with the disease and on the disease process, rather than on family caregivers (Carter et al., 1998). However, caregivers are now considered to be a major

Table 5 Spearman correlations of S-CGQoL scores with age, caregiver age at onset of illness, and PANSS score of the patient (n = 246). PsPhW Caregiver Age Patient Age at onset of illness Total PANSS Positive factor Negative factor Excitement Disorganization symptoms Emotional distress 0.12 PsBDL 0.20 RS 0.14 RPT 0.03 RFa 0.08 0.18 0.05 0.10 0.01 0.05 0.06 0.10 RFr 0.20 MB 0.09 Index 0.01

0.07 0.13 0.09 0.00 0.09 0.05 0.09

0.15 0.09 0.13 0.04 0.07 0.10 0.00

0.14 0.08 0.00 0.06 0.09 0.01 0.23

0.05 0.09 0.09 0.15 0.02 0.04 0.09

0.06 0.17 0.19 0.08 0.11 0.11 0.09

0.17 0.13 0.10 0.10 0.03 0.11 0.13

0.24 0.21 0.18 0.14 0.11 0.09 0.22

S-CGQoLPsPhW: Psychological and Physical Well-being; PsBDL: Psychological Burden and Daily Life; RS: Relationships with Spouse; RPT: Relationships with Psychiatric Team; RFa: Relationships with Family; RFr: Relationships with Friends; MB: Material Burden; Index, global S-CGQoL score. S-CGQoL scores, ranging from 0 to 100 (with 100 indicating best quality of life). p b 0.05. p b 0.01.

Please cite this article as: Richieri, R., et al., The Schizophrenia Caregiver Quality of Life questionnaire (S-CGQoL): Development and validation of an instrument..., Schizophr. Res. (2010), doi:10.1016/j.schres.2010.08.037

R. Richieri et al. / Schizophrenia Research xxx (2010) xxxxxx

component in delivering an integral service to individuals with schizophrenia and their families. For example, Caqueo-Urizar et al. (2009) suggest that the development of supporting activities for the family is an important concern, and they warn that focusing solely on symptom reduction and relapse prevention is insufcient. There is a need for improved family intervention programs that can be delivered by health services teams. Pursuant to this, providing a reliable and valid instrument for the family caregivers of individuals with schizophrenia is necessary. The S-CGQoL assesses signicant family factors that must be discussed when planning care for an individual with schizophrenia. First, identifying the components of the questionnaire based on face-to-face interviews strengthens the content validity of the nal version of the current questionnaire. Although it is now generally agreed that the content of QoL measures should be derived directly from relevant persons (patients, caregivers, etc.) because of discrepancies between them and experts' point of view (Slevin et al., 1988), the majority of available questionnaires for caregivers of individuals with schizophrenia (on burden, caregiving, coping strategies and opinions on the causes and consequences of mental disorders) are based only on the physicians' or experts' point of view, except for the Experience of Caregiving Inventory (Szmukler et al., 1996). The content of the S-CGQoL encompasses experiences of great importance to patients and is substantially different from other generic QoL or burden instruments. The low correlations with the SF-36 show that the S-CGQoL shares certain common themes with generic QoL instruments but not to a degree that would suggest that SCGQoL measures the same elements. In the same way, some dimensions of the S-CGQoL are similar to those referred to, in both the literature and existing tools, as Psychological and Physical Well-being, Psychological Burden and Daily Life, and Material Burden. However, some dimensions, like Relationships with Psychiatric Teams, emerged as specic concerns of caregivers of individuals with schizophrenia. On detecting a problem or a decrease in Relationships with Psychiatric Teams, the clinician will intervene in some way to address this. This extra information can be gained as a result of the QoL measure, prompting discussion with the patient. Kikkert et al. (2006) reported a positive inuence on adherence if professionals focus on positive aspects of medication, enhancing insight, and fostering a positive therapeutic relationship with patients and caregivers. The focus on the different aspects of the social life (relationships with spouses, family, and friends) also permits a precise analytical description of the social dimension that is not often assessed in other questionnaires. Second, our proposal meets standards concerning psychometric properties. The goals of the study were to test the validity and reliability of the instrument's internal structure and to provide a rst assessment of its external validity, to support the interpretation of the S-CGQoL scores. The internal structure, supported by a high internal consistency (74.4% of the total variance), conrmed that caregivers' QoL is a multidimensional concept. Internal consistency reliabilities for the seven dimensions were shown to be high (Cronbach's alpha N 0.70). DIF analyses were satisfactory and constitute an interesting property rarely studied in other questionnaires.

We can speculate that responses to S-CGQoL are comparable according to the responders' characteristics. External validity, explored by the use of socio-demographic and clinical characteristics, globally conrmed our assumptions. We found a positive association between QoL and caregivers' age for two dimensions: PsBDL and RS. This result is concordant with the majority of studies that found that older caregivers perceive less burden, either because they have greater tolerance or resignation, better coping strategies or because improvements occur in patients' symptoms (Gutierrez-Maldonado et al., 2005; Magliano et al., 2005). On the contrary, older caregiver age was associated with a lower score on the Relationships with Friends dimension, which may account for the progressive damage of schizophrenia in caregivers' social life (Webb et al., 1998). As expected, women had lower QoL than men within the dimensions of psychological well-being, physical well-being and relationship with spouse. Most studies show that mothers are generally the primary caregivers and that they have a lower QoL than other types of informal caregivers (Caqueo-Urizar et al., 2009). Gutierrez-Maldonado et al. (2005) reported that mothers experienced the greatest burden because they were responsible for most aspects of the patients' daily care. Looking at the inuence of the number of children on caregivers' QoL, we found that caregivers with more than one child reported higher QoL. One explanation is that having additional people in the household provided additional assistance in the care, especially for material burden (Li et al., 2007). Working life was signicantly associated with QoL in our study. Our results suggest that the absence of employment can improve relationships with spouse but deteriorate relationships with friends. For Magliano et al. (2003), professional and social network supports represent crucial resources for reducing family burden in schizophrenia. The absence of employment can result in an investment in household duties and care for individuals with schizophrenia, which can rob caregivers of an extra-familial social life. The living situation of caregivers and their patients is also an important factor associated with QoL, and our results support the fact that opportunities for residential care should in principal increase family QoL (Roick et al., 2007). Another result related to the age of the patient at the onset of the disease supports the external validity of our study. Older age was associated with a higher QoL level for the caregiver. This result makes sense, as individuals with youthonset schizophrenia have severe cognitive decits, whereas those with late-onset schizophrenia have relatively preserved cognitive functioning (Rajji et al., 2009). This nding supports the view that severity of the disease process is associated with different ages of onset. We also found that S-CGQoL scores were negatively correlated with the severity of psychotic symptoms (PANSS), mainly for positive symptoms and emotional distress. This result is consistent with previous studies, which often report that positive symptoms represent the greatest strain on family members (Caqueo-Urizar et al., 2009). Additionally, emotional distress, which includes depression symptoms, is known to be highly correlated

Please cite this article as: Richieri, R., et al., The Schizophrenia Caregiver Quality of Life questionnaire (S-CGQoL): Development and validation of an instrument..., Schizophr. Res. (2010), doi:10.1016/j.schres.2010.08.037

R. Richieri et al. / Schizophrenia Research xxx (2010) xxxxxx AL, LB, MCS and PA managed the statistical analysis. All authors contributed to and approved the nal manuscript. Conict of interest The authors report no conict of interest. Acknowledgements None.

with the QoL of individuals with schizophrenia (Reine et al., 2003a). This may explain the correlation between emotional distress and the QoL of caregivers, who may be affected by the well-being of individuals with schizophrenia. These correlations were moderate in strength, stressing the particular interest of relying on a QoL measurement to complement the clinical approach, which does not encompass the whole experience of patients and their caregivers. Finally, according to the usual parameters, the acceptability of S-CGQoL is good. The rate of missing data was low, between 0.4 and 7.7% for the seven dimensions. The average completion time is expected to be around ve minutes, which will facilitate its use in research and clinical practice. 4.1. Limitations and further development Several limitations must be noted. First, the sample may not be representative of the entire population of caregivers of individuals with schizophrenia. Further work is needed to test our questionnaire's strengths and weaknesses in various national and cultural contexts. The psychometric properties need to be studied in a wider population, including spouses, siblings and children of individuals with schizophrenia. Indeed, spouses, siblings, children and other relatives may experience unique impairments in QoL. It would be interesting to investigate differences in QoL impairment between caregivers from these various categories. Nonetheless, this limitation of the current work is moderated by the fact that parents represent the majority of caregivers for individuals with schizophrenia. Second, it is necessary to reinforce external validity by studying the relationships between S-CGQoL and burden, caregiving or opinion instruments, which are currently the most widely used with caregivers of individuals with schizophrenia. Finally, the reproducibility of these results and their sensibility to change should be explored in future studies. This property is of major interest for the follow-up of caregivers and patients in clinical practice and for psychosocial program researches. 5. Conclusion The S-CGQoL is not intended to replace available questionnaires on burden, caregiving and opinions. Rather, the SCGQoL adds interesting information that is oriented toward a more global service to individuals with schizophrenia and their families. It would be important to explore the reproducibility of the current results and their sensitivity to change. However, reliability and validity of S-CGQoL are evidenced by our results. Our approach provides an original, valid and valuable tool that may be useful in routine practice and clinical research.

Appendix A. List of the 25 S-CGQoL items

French items Au cours des 12 derniers mois, avez-vous 1 2 3 4 5 6 t triste, dprim? t moralement fatigu, us? manqu d'nergie? t physiquement fatigu, us? t angoiss, inquiet? d renoncer des choses qui vous tenaient cur? d diminuer le temps rserv vos loisirs (sorties, jardinage, shopping, bricolage...)?

Item general meaning For the last 12 months, have you felt sad, depressed? felt overworked, burnt-out? lacked energy? been tired, worn-out? felt anxious, worried? had to give up doing things that you were very keen to do? had to reduce the amount of time devoted to your leisure activities (outings, gardening, shopping, odd jobs)? been embarrassed to leave your child to attend your day or professional life? had the feeling that you didn't devote enough time to the rest of your family? had the feeling that you weren't free? had the feeling that you led a day-to-day existence? had difculty in making professional or personal plans?

Dimensions

PsPhW PsPhW PsPhW PsPhW PsPhW PsBDL

PsBDL

t gn de laisser votre enfant pour assumer vos tches de la vie quotidienne ou professionnelles? 9 eu le sentiment de ne pas consacrer le temps ncessaire au reste de votre famille? 10 eu le sentiment de manquer de libert? 11 eu le sentiment de vivre au jour le jour? 12 eu des difcults faire des projets professionnels ou personnels? 13 t aid(e), soutenu(e) par votre conjoint? 14 t cout, compris(e) par votre conjoint? 15

PsBDL

PsBDL

PsBDL PsBDL

PsBDL

16

17 Role of Funding Source None. Contributors RR and LB wrote the manuscript. All authors designed the study and wrote the protocol. RR and LB managed the literature searches and analyses.

18

19

been helped, supported by your spouse? been listened to, understood by your spouse? eu une vie sentimentale had a satisfying et sexuelle satisfaisante? emotional and sexual life? t cout(e), compris(e) been listened to, par les soignants understood by doctors (mdecins, inrmires)? and nurses? t aid(e), soutenu(e) been helped, supported par les soignants by doctors and nurses? (mdecins, inrmires)? been satised with t satisfait(e) des informations donnes par information given by les soignants (mdecins, doctors and nurses? inrmires)? t aid(e), soutenu(e) been helped, supported par votre famille? by your family?

RS RS

RS

RPT

RPT

RPT

RFa

Please cite this article as: Richieri, R., et al., The Schizophrenia Caregiver Quality of Life questionnaire (S-CGQoL): Development and validation of an instrument..., Schizophr. Res. (2010), doi:10.1016/j.schres.2010.08.037

R. Richieri et al. / Schizophrenia Research xxx (2010) xxxxxx (continued) Appendix A (continued ) French items Au cours des 12 derniers mois, avez-vous 20 t cout, compris(e) par votre famille? 21 t aid(e), soutenu(e) par vos amis, votre entourage? 22 t cout, compris(e) par vos amis, votre entourage? 23 rencontr des difcults dans vos dmarches administratives lies la maladie? 24 eu des difcults nancires pour faire face la maladie? 25 eu des difcults matrielles (logement, transport)? Item general meaning For the last 12 months, have you been listened to, understood by your family? been helped, supported by your friends? been listened to, understood by your friends? encountered difculties because of your child's illness when applying to administration departments? had nancial troubles in facing your child's illness? had material difculties (housing, transport)? RFa Dimensions

RFr

RFr

MB

MB

MB

S-CGQoLPsPhW: Psychological and Physical Well-being; PsBDL: Psychological Burden and Daily Life; RS: Relationships with Spouse; RPT: Relationships with Psychiatric Team; RFa: Relationships with Family; RFr: Relationships with Friends; MB: Material Burden. The use of the S-CGQoL is free of authors' royalty fees. Researchers wishing to use the S-CGQoL should contact Laurent Boyer (laurent.boyer@ap-hm.fr), who will give them all of the information on the questionnaire.

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