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Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire
JBUR-4931; No. of Pages 8 burns xxx (2016) xxx–xxx
Available online at www.sciencedirect.com
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Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire S. Gandolfi a, I. Auquit-Auckbur b, S. Panunzi c, E. Mici d, J.-L. Grolleau a, B. Chaput a,* a
Plastic and Reconstructive Surgery Unit, Faculty of Medicine, University Toulouse Rangueil, CHU Rangueil, 1, Avenue Jean-Poulhe`s, 31059 Toulouse, France b Plastic and Reconstructive Surgery Unit, Faculty of Medicine, University Rouen, CHU Charles Nicolle, France c CNR-Istituto di Analisi dei Sistemi ed Informatica ‘‘A. Ruberti’’ (IASI), BioMatLab, Rome, Italy d Unit of Maxillo-Facial Surgery, University of Rome ‘‘Sapienza’’, Azienda Ospedaliera Universitaria ‘‘Sant’Andrea’’, Rome, Italy
article info
abstract
Article history:
Introduction: The Burn Specific Health Scale-Brief questionnaire is a widely validated tool for
Accepted 14 April 2016
estimating the health related quality of life and for assessing the best multidisciplinary
Keywords:
and to investigate its reliability and validity.
Quality of life
Methods: According to the procedure proposed by the Scientific Advisory Committee of the
management of burn patients. The aim of this study was to translate the BSHS-B into French
Validation
Medical Outcomes Trust, the Burn Specific Health Scale-Brief (BSHS-B) was translated from
French BSHS
the English version into French. In order to test the reliability of the French version of the
Burn
BSHS-B, 53 burn patients French speakers completed the BSHS-B and SF-36 questionnaires
Multidisciplinary management
from two to four years after burn. Ten of them have been re-tested at 6 months after the first evaluation. To evaluate clinical utility of the BSHS-F, internal consistency, construct validity (using SF-36) and stability in time were assessed using Cronbach’s alpha statistic, Spearman rank test, and intra-class correlation coefficient respectively. Results: The French version of the BSHS-B Cronbach’s alpha coefficient was 0.93 and was >0.80 for all the sub-domains. French version of the BSHS-B and the SF-36 were positively correlated, all the associations were statistically significant ( p < 0.01). Intra-class correlation coefficients for test–retest ranged between 0.95 and 0.99 for the sub-domains. The intraclass correlation coefficient (ICC) for the total score was 0.98. Conclusion: The French version of the BSHS-B shows a robust rate of internal consistency, construct validity and stability in time, supporting its application in routine clinical practice as well as in international studies. # 2016 Elsevier Ltd and ISBI. All rights reserved.
* Corresponding author at: Department of Plastic Reconstructive Surgery and Burns, CHU Rangueil, 1, Avenue Jean-Poulhe`s, 31059 Toulouse, France. Tel.: +33 672391770; fax: +33 561322742. E-mail address: [email protected] (B. Chaput). http://dx.doi.org/10.1016/j.burns.2016.04.011 0305-4179/# 2016 Elsevier Ltd and ISBI. All rights reserved.
Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011
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1.
Introduction
2.
1.1.
Health related quality of life in burn patients
The study project was approved by the clinical team of the Plastic, Reconstructive and Burn Surgery department of Rangueil University hospital in Toulouse (France). All participants were informed about the study’s objective and provide written informed consent. Anonymity was maintained during patient inclusion.
Burn patients suffer a serious traumatic injury causing both esthetic-functional and psycho-social sequelae. In particular, severe burns lead to important psychological repercussions which consist in part in self-image, relationships and communication’s problems, that significantly deteriorate the quality of life of these patients. In addition, burn patients suffer from post-traumatic stress disorder [1] and they are subjected to long and constraining treatments (including psychiatric treatment [2]), which often lead to considerable difficulties in the returning to work [3,4]. Burn survivors show important family difficulties and bad social integration [5–7]. It is accepted that both psychological and physical consequences of burns account for mild to severe impairment and disability, and significantly affect health related quality of life (HRQoL) [8]. The quality of life (QoL) is still a recent concept even that its evaluation is in constant development. The World Health Organization (1994) defines ‘‘Quality of life as individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. It is a broad ranging concept affected in a complex way by the person’s physical health, psychological state, level of independence, social relationships, personal beliefs and their relationship to salient features of their environment’’. QoL evaluation is expressed through a multidisciplinary assessment, both qualitative and quantitative, and it is based on the exploration of different dimensions (physical, cognitive, and behavioral). In burned patients, QoL is often severely altered and this alteration depends very often on total body surface area involved and on the incriminated zone: burns at the hands and at the cephalic extremity level [9] are particularly implicated in problems of self-image and in alterations of own social role. QoL scales are extremely useful tools but unfortunately still not widely used in current clinical practice. In our opinion these types of scales have several functions: they are helpful both for patients to become more aware of their physical and mental state and to understand their needs and their progress, and both for physicians to understand if there is satisfaction or dissatisfaction of patients compared with their health state and, if so, proceed in the appropriate management. They can also be useful in terms of research, to establish for example a gold standard between different types of treatments.
1.2.
Aim of the study
The purpose of this present study is to propose the French translation of the BSHS-B and to present the results of a French validation project, assessing the internal consistency (reliability of the scales) by Cronbach’s alpha and the construct validity through correlations with the Short Form 36 Health Survey Questionnaire (SF-36). Through its translation and the possible cultural adaptation we could achieve a widely used validation in France and French speaking countries.
2.1.
Materials and methods
Study design
The study was conducted in two steps: translation and cultural adaptation at first, and cross-sectional validation at last.
2.2.
Sample
In order to test the reliability of the French version of the BSHSB, this questionnaire and the Short Form 36 Health Survey Questionnaire (SF-36) [10,11] were administered to a sample of 53 burn patients (66% males), from 18 to 70 years old, admitted at first to the Plastic Surgery and Burns Therapy ward (Centre Hospitalier Universitaire de Rangueil, Toulouse, France) from January 2007 to January 2012. We included patients presenting a percentage of total body surface area (TBSA) from 10% to 54%, all with deep burns (deep second degree and third degree). We excluded psychiatric and pediatric populations, patients who had undergone the burn for less than 2 years at the time of the study (healing process cannot be considered completed before this period), patients with a total body surface area (TBSA) <10% and suffering from superficial burns. The responders and the non-responders group were compared in terms of age, gender, and burn size. The two instruments were administered by the same plastic surgeon during hospital visits in a period of one year (from January 2014 to January 2015). In only one case the instrument was sent to the patient and sent back to the investigator by ordinary mail.
2.3.
Instruments
The instruments used to collect data for the health related quality of life of burn patients were the French version of the SF-36 questionnaire [11] and the BSHS-B questionnaire [12] that was translated to French (BSHS-F, see Appendix A).
2.3.1.
Short-Form 36 Health Survey (SF-36)
The Short Form 36 Health Survey Questionnaire (SF-36) is a scale built from the Medical Outcomes Study (MOS), used to measure the overall state of health and quality of life [10]. It consists of 36 items grouped into 8 main domains (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health). It has already been used to evaluate the quality of life in patients with burns [12] and it has shown its validity and reliability in French [11]. Actually, this 36-item questionnaire remains one of the most widely used measures of generic HRQoL assessments.
Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011
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2.3.2.
Burn Specific Health Scale-Brief (BSHS-B)
QoL of burn patients is assessed by the Burn Specific Health Scale (BSHS), developed in 1982 by the group of Baltimore Regional Burn Center in the United States [13] and initially consisted of 369 items, subsequently reduced to 114. The scale was then abbreviated into 80 items (The Abbreviated Burn Specific Health Scale – BSHS-A), measuring four major domains (Physical, Mental, Social, General). The scale was revised by Blalock et al. [14] (The Revised Burn Specific Health Scale – BSHS-R), resulting in 31 items. In this scale the exploration of hand function and sexuality were excluded. Finally, in 2001, a shorter but complete version was produced by Kildal et al.: the Burn Specific Health Scale-Brief (BSHS-B) [15]. This scale is the most cited in literature and is widely use in general practice: it is based on simple questions and it takes approximately 10–15 min to be completed. The Burn Specific Health Scale-Brief (BSHS-B) consists in 40 items grouped in nine sub-domains: simple abilities (3 items), hand function (5 items), work (4 items), body image (4 items), heat sensitivity (5 items), treatment regimens (5 items), affect (7 items), interpersonal relationships (4 items), and sexuality (3 items). Each item describes a particular task or experience that burn patients have to evaluate on a scale from 0 (extreme) to 4 (not at all). The nine sub-domains were built following Kildal et al. [15]. A recent factor analysis [8,16,17] showed that, with the exception of work, all the above sub-domains can be grouped into three major domains: the function domain (simple abilities and hand function), the skin sensitivity domain (body image, heat sensitivity, and treatment regimen), and the affect and relationship domain (affect, interpersonal relationship, and sexuality). Mean scores were calculated for each of the sub-domains, for the three majors domains, as well as the overall scale. Consistently with other HRQoL scales, lower scores of the BSHS correspond to a worse quality of life. BSHS has been used in several countries and has been translated and validated in Norwegian [18], Italian [19], Persian [20], Turkish [16], Chinese [8,21], Spanish [22] and Hebrew [23].
2.3.3.
BSHS-B translation procedure
According to the procedure proposed by the Scientific Advisory Committee of the Medical Outcomes Trust [12], three experienced independent interpreters translated the Burn Specific Health Scale-Brief (BSHS-B) from the English version into French language. The translation was then developed by consensus using a fourth expert. At second, we included a back translation from the common French version to English by an independent translation version written by a professional English translator. We then compared the translations to harmonize the final French translation. A simple transposition does not appear to be sufficient [10,24], and in this manner we tried to apply a cultural adaptation, according to the fact that the perception of quality of life in Latin countries can be quite different from that of the Anglo-Saxon countries, but no major differences were found.
2.4.
Data collection
101 eligible burn patients were initially approached by phone and invited to attend the study. 53 responders patients
3
received during a hospital visit the SF-36 and BSHS-B French version questionnaire. In order to avoid the ‘‘order effect’’ each questionnaire was randomly assigned by the same Plastic Surgeon (SG). In only one case both instruments were sent to the patient and sent back to the investigator by ordinary mail. Socio-demographic and clinical information was collected for every patient. Stability in time of the BSHS-B French version was evaluated using test–retest analysis [23,25,26] for 10 patients after 6 months from the first evaluation.
2.5.
Psychometric documentation
Reliability: the internal consistency of the French BSHS-B was assessed for each sub-domains and major domain, as well as for the overall scale. Construct validity: SF-36 was chosen as the gold standard measure for HRQoL and correlations with the French BSHS-B sub-domains were analyzed to assess the construct validity. Stability: the test–retest method was performed at 6 months to assess the stability of the French BSHS-B over the time.
2.6.
Statistics
All analyses were performed with the software R [27]. Subdomain’s scores of the BSHS-B questionnaire were computed as the percentage ratio between the sum of the scores of the relative items and the maximum score attainable for that subdomain. Results related to each sub-domain from the two instruments are reported in terms of mean, standard deviation and median. Categorical or nominal variables are presented as counts and percentages with 95% confidence interval. Construct validity is one of the most important measurement characteristic for a scale. In order to evaluate the construct validity, the literature recommends evaluating the relationship between similar constructs measurement scale [21]. Reliability of the French version of the BSHS-B questionnaire was assessed by Cronbach’s alpha measuring internal consistency, while construct validity was assessed by Spearman correlations with the domains of the SF-36 scale. It was considered acceptable when Cronbach’s-a value was above 0.7 [28]. Test–retest was assessed using a type C intra-class correlation coefficient (ICC) that was calculated using a twoway random effects model. We assessed the test–retest for the nine sub-domains. ICC is presented with 95% confidence interval and p value. ICC above 0.7 was considered appropriate for a good test–retest [29]. As performed in the Chinese BSHS-B, floor and ceiling effects may influence the reliability, validity and responsiveness of an instrument [8]. These effects would be considered present if >15% of the respondents achieved the highest or lowest possible score.
3.
Results
3.1.
Baseline characteristics
We admitted 385 patients during the years 2007–2012 in our burn therapy ward. Of these, 101 patients were eligible for
Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011
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participation. Ultimately, 53 patients were responders (52.47%) and 10 of these completed the questionnaire twice to attend the test–retest reliability (Fig. 1). The analyzed sample consisted of 53 patients, especially male patients (66% males), more often with suspended work after burn. The average age was approximately 46 years old (46.4 15.9); the total body surface area (TBSA) was approximately of 27% (26.9 15.9 [range: 10–54%]). Table 1 reports the characteristics of the studied sample. All subjects enrolled in the study completed the two questionnaires (SF-36 and BSHS-B French version) and the interval between the burn and the QoL evaluation was 24–60 months. Test–retest group burn to questionnaire time interval was at least 6 months. Table 2 reports mean and median values in each domain for the SF-36 scale.
3.2.
Response bias analysis
There were no difference in terms of age, sex, and burn size between the responders and the non-responders ( p > 0.05).
3.3.
BSHS-B French version
Reliability: internal consistency was calculated for the whole instrument, and separately for the nine sub-domains using Cronbach’s alpha value. For all sub-domains Cronbach’s alpha resulted equal to or larger than 0.8, with the highest level for 5 sub-domains (Affect, Hand Function, Treatment Regimens, Work, Sexuality) and for the whole instrument (total score for alpha value was 0.93) (Table 3). Validity: construct validity was investigated through correlation with the SF-36 questionnaire. Table 4 reports Spearman correlations along with the relative p values, and shows SF-36’s domains that have been included in the major domains of the BSHS-F. All the correlations were found statistically significant ( p < 0.01) with Spearman’s coefficient ranging from 0.3 to 0.9. Stability: intra-class correlation coefficients for test–retest ranged between 0.95 and 0.98 (Table 5). The intra-class correlation coefficient (ICC) for the total score was 0.98. There were no differences in terms of age, sex, and burn size between tests and the re-tests participants ( p < 0.05).
Table 1 – Demographic data of burn patients (N = 53). Age (mean SD) Gender, N (%) Female Male TBSA, % (mean SD) Mild burn, N (%) Moderate burn, N (%) Severe burn, N (%) Burn localization, N (%) Cephalic area Upper limb Hands Lower limb Chest Abdomen Dorsal region Perineum Etiology of burn, N (%) Hot water Flames Explosion of gas Hot oil Suicide attempt Others Activity, N (%) Unemployed Worker Part-time worker Retired Suspended Student
46.4 15.9 18 (34) 35 (66) 26.9 15.9 13 (24.5) 19 (35.8) 21 (39.6) 27 18 18 13 26 11 10 1
(50.9) (33.9) (33.9) (24.5) (49.0) (20.7) (18.9) (1.8)
13 10 8 5 4 13
(24.5) (18.8) (15.0) (9.4) (7.5) (24.5)
5 9 1 11 20 7
(9.4) (17.4) (1.9) (20.8) (37.7) (13.2)
Feasibility and clarity assessment: the completion time of BSHS-B French version questionnaire was 11 min in average (range: 9–14 min). Floor and ceiling effects: neither floor effects (indicating worst possible score) nor ceiling effects (indicating best possible score) were found for the three majors domains.
4.
Discussion
No French validation of the BSHS-B was so far available in the literature. In this sense, we wanted to provide the French version of the BSHS-B widely exploitable to evaluate the HrQoL
Fig. 1 – Demographic data of burn population between 2007 and 2012 in our burn center.
Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011
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Table 2 – Domain average scores of the SF 36.
Physical Functioning Role-Physical Bodily Pain General Health Social Functioning Mental Health Role-Emotional Vitality
Mean
SD
Median
67.5 22.6 61.7 63.1 61.3 46.8 42.1 39.4
23.1 29.5 19.5 16.2 29.7 19 40.4 19
70 0 62 72 62.5 48 33.3 35
of burn patients in French population and in French-speaking countries. The completion time of 11 min on average was very satisfactory and compatible with its use in routine clinical practice. All patients considered that the French version of BSHS-B was quite easy to read and understand, which is a crucial element for a correct QoL evaluation. We highlighted a good internal consistency of the French BSHS-B with 0.93 concerning the total score of the Cronbach’s alpha coefficients and above 0.8 for the three major domains. The overall scale coefficient appears close to previously published studies on this subject as Chinese (0.97), Hebrew (0.97), Persian (0.95), or Italian (0.89). Reliability of the French BSHS-B was very satisfying as no sub-domains were lower than 0.7 as recommended (0.78–0.93), similarly to the original study of Kildal and other translations of the BSHS-B available in literature [8,15–23]. Cronbach’s alpha values resulted equal to or larger than 0.8, with highest levels for five sub-domains (Affect, Hand Function, Treatment Regimens, Work, Sexuality) and for the whole instrument (>0.9), suggesting an excellent rate for internal consistency [30]. Lower values results, but close to 0.8, were found in the Heat Sensitivity sub-domain (where no correlations are found between the two scales), and the Interpersonal Relationships subdomain. Construct validity was investigated through correlations with the generic instrument SF-36. For the SF-36 the lowest average score was observed for the ‘‘Physical Role’’ domain (mean 22.6), which describes the aspects related to the
Table 3 – Domain average scores of the BSHS-B questionnaire along with p values and Cronbach alpha. Cronbach alpha Function domain Simple abilities Hand function Skin involvement domain Heat sensitivity Treatment regimens Body image Affect and relationship domain Sexuality Interpersonal relationship Affect Work Total score
0.79 0.83 0.78 0.9 0.79 0.81 0.78 0.93 0.89 0.93
Table 4 – Correlations (Spearman) between BSHS-B and SF-36. BSHS-B
SF-36
Spearman’s rho
p
Heat sensitivity
No correlations
–
Affect
Role-Physical General Health Social Functioning Mental Health Role-Emotional Vitality
0.4 0.7 0.8 0.9 0.8 0.8
0.006 <0.001 <0.001 <0.001 <0.001 <0.001
–
Hand function
Physical Functioning Role-Physical Bodily Pain General Health Vitality
0.8 0.4 0.7 0.4 0.3
<0.001 <0.001 <0.001 0.004 0.015
Treatment regimens
General Health
0.4
0.008
Social Functioning Mental Health Role-Emotional Vitality
0.4 0.7 0.5 0.5
0.001 <0.001 <0.001 <0.001
Work
Role-Physical Social Functioning Role-Emotional
0.6 0.3 0.4
<0.001 0.029 0.001
Sexuality
Bodily Pain General Health Social Functioning Mental Health Role-Emotional Vitality
0.3 0.6 0.6 0.6 0.6 0.6
0.019 <0.001 <0.001 <0.001 <0.001 <0.001
Interpersonal relationship
General Health
0.5
<0.001
Social Functioning Mental Health Role-Emotional Vitality
0.8 0.8 0.6 0.6
<0.001 <0.001 <0.001 <0.001
Simple abilities
Physical Functioning Role-Physical Bodily Pain General Health Mental Health Role-Emotional Vitality
0.7 0.4 0.7 0.5 0.3 0.4 0.6
<0.001 0.002 <0.001 <0.001 0.015 0.007 <0.001
Body image
General Health Social Functioning Mental Health Role-Emotional Vitality
0.5 0.7 0.7 0.6 0.5
<0.001 <0.001 <0.001 <0.001 <0.001
limitation of the time dedicated to work as well as to the difficulty in carrying out work-related activities. This correlates with the fact that most of the patients, in the sample studied, have suspended their work after the occurred burn or sequentially to treatments carried them out. The French version of BSHS-B (BSHS-F), exhibits positive correlations with SF-36, showing good construct validity. Highest correlations were found between Mental Health of the SF-36 and Affect of the BSHS-F, Physical Functioning of the SF-36 and Hand Functioning of the BSHS-F, Social Functioning of the SF-36 and Interpersonal Relationships of the BSHS-F.
Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011
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Table 5 – Test–retest reliability of the BSHS-B questionnaire (n = 10). First score
Second score
ICC
Confidence interval 95%
p value
Mean
SD
Mean
SD
Heat sensitivity Affect Hand function Treatment regimens Work Sexuality Interpersonal relationship Simple abilities Body image
11.8 15.3 16.1 10 8.4 6 13.7 10.2 7.5
2.78 6.86 4.41 5.56 3.50 2.66 2.98 2.04 2.88
11.8 16.3 16.6 10 8.9 6.6 13.7 10.1 8
3.04 6.96 4.01 5.29 3.35 2.86 2.87 2.08 3.16
0.99 0.98 0.97 0.97 0.96 0.96 0.99 0.96 0.95
0.91–1 0.81–1 0.88–0.99 0.89–0.99 0.95–1 0.54–0.99 0.96–1 0.87–0.99 0.74–0.99
<0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
Total score
99
3.50
3.55
0.98
0.84–1
<0.001
102
Correlation’s analysis of these two instruments (SF-36 and BSHS-F) showed that the deterioration of physical function and social relations leads to significantly affect the overall quality of life in our sample of patients, the scores being lower in these domains. These two aspects (physical dysfunction and loss of social relations), may be consequential, indeed in most cases physical dysfunctions related to post-burn sequelae determine suspension of work and common activities by patients, resulting in fewer opportunities for social gatherings. Test–retest reliability is a reflection of the stability of a questionnaire in a defined period of time and has been successfully used in the Hebrew translation of the BSHS-B by Stavrou et al. [19,26]. In our study, patients have been re-tested at least at 6 months and the BSHS-F showed high ICC values ranging from 0.95 to 0.99, demonstrating a good stability in time. The total score ICC was 0.98. Similar results were found in previous studies for validation of the Persian version and the Hebrew version [20,23]. Some limitations of this study relate to the small sample of patients (n = 53) in only one Burn unit and the test–retest analysis was conducted on a relatively small sample size (n = 10). Nonetheless, the excellent results in terms of internal consistency, construct validity and stability in time, are encouraging and prelude to the use of the BSHS-B French version at first, at national level, then in international studies.
5.
Conclusion
Our French version of the BSHS-B shows a good rate of internal consistency, construct validity and stability in time supporting its application in routine clinical practice and lays the groundwork to a multicenter French validation study. Through this version, French-speaking countries will be able to make use of the BSHS-B to evaluate the health related quality of life of burn patients. We need to focus on the fact that the use of quality of life scales has to become routine in medical practice, especially in burn patients who require a multidisciplinary management, as well as a long-term followup.
Conflict of interest All authors do not have any financial and personal relationships with other people or organizations that could inappropriately influence their work.
Acknowledgement The study was not funded by any external source.
Appendix A. French version of the Burn Specific Health Scale-Brief (BSHS-F) il s’agit d’un score pour l’e´valuation de la qualite´ de vie du patient brule´, il requiert 10 a` 15 minutes. Il est comple`tement anonyme. Ces informations nous permettront de mieux savoir comment vous vous sentez dans votre vie de tous les jours. Veuillez re´pondre a` toutes les questions en entourant le chiffre correspondant a` la re´ponse choisie. Si vous n’eˆtes pas certain de votre re´ponse, choisissez la re´ponse la plus proche de votre situation.
1. 2. 3.
Avez-vous des difficulte´s a`? ` vous laver de fac¸on autonome? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2 Un peu = 3; Aucune (Absolument pas) = 4 ` vous habiller vous-meˆme? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4 ` vous asseoir et a` vous lever d’une chaise? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4
Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011
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4. 5. 6. 7. 8. 9.
10. 11. 12. 13. 14. 15.
16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34.
` signer? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ ` manger avec des couverts? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ ` lacer vos chaussures? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ ` attraper des pie`ces de monnaie au sol? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ ` de´verrouiller une serrure? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ ` effectuer votre ancien me´tier? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´
(ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4 (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4 (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4 (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4 (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4 (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4
Dans quelle mesure chacun des e´nonce´s suivants vous correspond? Je suis envahi par un sentiment de solitude Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Jamais (Absolument pas) = 4 Souvent je me sens triste ou avec une humeur de´pressive Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Jamais (Absolument pas) = 4 A certains moments, j’ai des proble`mes e´motionnels Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Jamais (Absolument pas) = 4 Je n’ai pas envie de faire des activite´s avec mes amis Jamais envie = 0; rarement envie = 1; Mode´re´ (ment) envie = 2; assez souvent envie = 3; tre`s souvent envie = 4 Je n’aime plus rendre visite a` mes connaissances Plus du tout = 0; beaucoup moins = 1; Mode´re´ (ment) = 2; Un peu moins = 3; Si, comme avant = 4 Je n’ai personne avec qui parler de mes proble`mes Absolument personne = 0; de rares personnes = 1; Quelques personnes = 2; Beaucoup de personnes = 3; Enorme´ment de personnes = 4 J’ai l’impression d’eˆtre pie´ge´ ou la sensation d’eˆtre emprisonne´ Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4 Mes brulures m’ont e´loigne´ de ma famille Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Je pre´fe`re eˆtre seul qu’avec ma famille Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Je n’aime pas la fac¸on dont ma famille agit autour de moi Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Ma famille serait mieux sans moi Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Je me sens frustre´ parce que je n’ai pas retrouve´ ma libido d’avant Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Clairement, je ne suis plus inte´resse´ par le sexe comme avant Plus du tout = 0; beaucoup moins = 1; Mode´re´ (ment) = 2; Un peu moins = 3; Si, comme avant = 4 Je n’embrasse plus, ou je n’e´treins plus comme avant Plus du tout = 0; beaucoup moins = 1; Mode´re´ (ment) = 2; Un peu moins = 3; Si, comme avant = 4 Parfois, je souhaiterais oublier avoir change´ d’aspect Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Je sens que ma brulure de´range les autres Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Mon aspect en ge´ne´ral m’est de´sagre´able Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 L’aspect des mes cicatrices me ge`ne Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Etre au soleil me de´range Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Les chaudes conditions climatiques me de´rangent Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Je n’arrive pas a` sortir ou faire des choses quand il fait chaud Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Ne pas pouvoir sortir quand il y a du soleil me de´range Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Ma peau est plus sensible qu’avant Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Soigner ma peau est pe´nible Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Je n’aime pas faire les soins qui m’ont e´te´ conseille´s pour mes bruˆlures Je n’aime extreˆme(ment) pas = 0; J’aime peu les faire = 1; Mode´re´ (ment) = 2; c¸a` me geˆne peu = 3; c¸a ne me geˆne pas du tout = 4
Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011
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35. 36.
37.
38. 39. 40.
Je pre´fe´rerais n’avoir rien a` faire pour le soin des mes bruˆlures Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument J’ai du mal a` faire toutes les choses conseille´es pour le soin des mes bruˆlures Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un Peu = 3; Absolument En prenant soin de mes bruˆlures, il m’est difficile de faire d’autres choses importantes pour moi Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un Peu = 3; Absolument Ma bruˆlures interfe`re avec mon travail Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un Peu = 3; Absolument Etre brule´ a affecte´ ma capacite´ a` travailler Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un Peu = 3; Absolument Ma bruˆlures a engendre´ des proble`mes dans mon travail Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un Peu = 3; Absolument
references
[1] Dyster-Aas J, Kildal M, Willebrand M. Return to work and health-related quality of life after burn injury. J Rehabil Med 2007;39:49–55. [2] Van Loey NE, Van Son MJ. Psychopathology and psychological problems in patients with burn scars: epidemiology and management. Am J Clin Dermatol 2003;4:245–72 [review]. [3] Brych SB, Engrav LH, Rivara FP, Ptacek JT, Lezotte DC, Esselman PC, et al. Time off work and return to work rates after burns: systematic review of the literature and a large two-center series. J Burn Care Rehabil 2001;22:401–5 [review]. [4] Esselman PC, Ptacek JT, Kowalske K, Cromes GF, deLateur BJ, Engrav LH. Community integration after burn injuries. J Burn Care Rehabil 2001;22:221–7. [5] Wallace LM, Lees J. A psychological follow-up study of adult patients discharged from a British burn unit. Burns Incl Therm Inj 1988;14:39–45. [6] Costa MC, Rossi LA, Lopes LM, Cioffi CL. The meanings of quality of life: interpretative analysis based on experiences of people in burns rehabilitation. Rev Lat Am Enfermagem 2008;16:252–9. [7] Elijah I, Edelman LS, Sabourin H, Dong L, Saffle JR, Cochran A. The social milieu of burn injury and recovery: using ‘‘social capital’’ as a framework for evaluating sex differences. J Burn Care Res 2008;29:123–9. [8] Li DW, Liu WQ, Wang HM, Ying-Sun, Cui L, Zhao FF. The Chinese language version of the abbreviated burn specific health scale: a validation study. Burns 2014;40:1001–6. [9] Solnit AJ, Priel B. Scared and scarred – psychological aspects in the treatment of soldiers with burns. Isr Ann Psychiatr Relat Discip 1975;13:213–20. [10] Ware Jr JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83. [11] Leple`ge A, Mesbah M, Marquis P. [Preliminary analysis of the psychometric properties of the French version of an international questionnaire measuring the quality of life: the MOS SF-36 (version 1.1)]. Rev Epidemiol Sante Publique 1995;43:371–9. [12] Jonsson CE, Schu¨ldt K, Linder J, Bjo¨rnhagen V, Ekholm J. Rehabilitative, psychiatric, functional and aesthetic problems in patients treated for burn injuries – a preliminary follow-up study. Acta Chir Plast 1997;39:3–8. [13] Blades B, Mellis N, Munster AM. A burn specific health scale. J Trauma 1982;22:872–5. [14] Blalock SJ, Bunker BJ, DeVellis RF. Measuring health status among survivors of burn injury: revisions of the Burn Specific Health Scale. J Trauma 1994;36:508–15.
pas = 4
pas = 4
pas = 4 pas = 4 pas = 4 pas = 4
[15] Kildal M, Andersson G, Fugl-Meyer AR, Lannerstam K, Gerdin B. Development of a brief version of the Burn Specific Health Scale (BSHS-B). J Trauma 2001;51: 740–6. [16] Adam M, Leblebici B, Tarim MA, Yildirim S, Bagis S, Akman MN, et al. Validation of a Turkish version of the burnspecific health scale. J Burn Care Res 2009;30:288–91 [discussion 292–3]. [17] Pusic AL, Chen CM, Cano S, Klassen A, McCarthy C, Collins ED, et al. Measuring quality of life in cosmetic and reconstructive breast surgery: a systematic review of patient-reported outcomes instruments. Plast Reconstr Surg 2007;120:823–37 [discussion 838–9. Review]. [18] Moi AL, Wentzel-Larsen T, Salemark L, Hanestad B. Validation of a Norwegian version of the Burn Specific Health Scale. Burns 2003;29:563–70 [erratum in: Burns 2003;29:872–3]. [19] Sideli L, Di Pasquale A, Prestifilippo A, Benigno A, Bartolotta A, Cirrincione CR, et al. Validation of the Italian version of the burn specific health scale-brief. Burns 2014;40: 995–1000. [20] Pishnamazi Z, Rejeh N, Heravi-Karimooi M, Vaismoradi M. Validation of the Persian version of the Burn Specific Health Scale-Brief. Burns 2013;39:162–7. [21] Ling-Juan Z, Jie C, Jian L, Xiao-Ying L, Ping F, Zhao-Fan X, et al. Development of quality of life scale in Chinese burn patients: cross-cultural adaptation process of burn-specific health scale-brief. Burns 2012;38:1216–23. [22] Salvador Sanz JF, Sanchez-Paya´ J, Rodriguez Marı´n J. Spanish version of the Burn-Specific Health Scale. J Trauma 1998;45:581–7. [23] Stavrou D, Haik J, Wiser I, Winkler E, Liran A, Holloway S, et al. Validation of the Hebrew version of the Burn Specific Health Scale-Brief questionnaire. Burns 2015;41:188–95. [24] Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med 1993;118:622–9 [review]. [25] Streiner D, Norman G. Health measurement scales. A practical guide to their development and use. 2nd ed. Oxford: Oxford University Press; 1995. [26] Carmines E, Altman D. Reliability and validity assessment. Newbury Park: Sage Publications; 1994. [27] R Development Core Team. R: A language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; 2008. [28] Bland JM, Altman DG. Cronbach’s alpha. BMJ 1997;314(7080):572. [29] Fayers P, Machin D. Quality of life, assessment analysis and interpretation. Chichester: Wiley; 2000. [30] Cui Y, Li J. Evaluating the performance of different procedures for constructing confidence intervals for coefficient alpha: a simulation study. Br J Math Stat Psychol 2012;65:467–98.
Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011
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Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire S. Gandolfi a, I. Auquit-Auckbur b, S. Panunzi c, E. Mici d, J.-L. Grolleau a, B. Chaput a,* a
Plastic and Reconstructive Surgery Unit, Faculty of Medicine, University Toulouse Rangueil, CHU Rangueil, 1, Avenue Jean-Poulhe`s, 31059 Toulouse, France b Plastic and Reconstructive Surgery Unit, Faculty of Medicine, University Rouen, CHU Charles Nicolle, France c CNR-Istituto di Analisi dei Sistemi ed Informatica ‘‘A. Ruberti’’ (IASI), BioMatLab, Rome, Italy d Unit of Maxillo-Facial Surgery, University of Rome ‘‘Sapienza’’, Azienda Ospedaliera Universitaria ‘‘Sant’Andrea’’, Rome, Italy
article info
abstract
Article history:
Introduction: The Burn Specific Health Scale-Brief questionnaire is a widely validated tool for
Accepted 14 April 2016
estimating the health related quality of life and for assessing the best multidisciplinary
Keywords:
and to investigate its reliability and validity.
Quality of life
Methods: According to the procedure proposed by the Scientific Advisory Committee of the
management of burn patients. The aim of this study was to translate the BSHS-B into French
Validation
Medical Outcomes Trust, the Burn Specific Health Scale-Brief (BSHS-B) was translated from
French BSHS
the English version into French. In order to test the reliability of the French version of the
Burn
BSHS-B, 53 burn patients French speakers completed the BSHS-B and SF-36 questionnaires
Multidisciplinary management
from two to four years after burn. Ten of them have been re-tested at 6 months after the first evaluation. To evaluate clinical utility of the BSHS-F, internal consistency, construct validity (using SF-36) and stability in time were assessed using Cronbach’s alpha statistic, Spearman rank test, and intra-class correlation coefficient respectively. Results: The French version of the BSHS-B Cronbach’s alpha coefficient was 0.93 and was >0.80 for all the sub-domains. French version of the BSHS-B and the SF-36 were positively correlated, all the associations were statistically significant ( p < 0.01). Intra-class correlation coefficients for test–retest ranged between 0.95 and 0.99 for the sub-domains. The intraclass correlation coefficient (ICC) for the total score was 0.98. Conclusion: The French version of the BSHS-B shows a robust rate of internal consistency, construct validity and stability in time, supporting its application in routine clinical practice as well as in international studies. # 2016 Elsevier Ltd and ISBI. All rights reserved.
* Corresponding author at: Department of Plastic Reconstructive Surgery and Burns, CHU Rangueil, 1, Avenue Jean-Poulhe`s, 31059 Toulouse, France. Tel.: +33 672391770; fax: +33 561322742. E-mail address: [email protected] (B. Chaput). http://dx.doi.org/10.1016/j.burns.2016.04.011 0305-4179/# 2016 Elsevier Ltd and ISBI. All rights reserved.
Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011
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1.
Introduction
2.
1.1.
Health related quality of life in burn patients
The study project was approved by the clinical team of the Plastic, Reconstructive and Burn Surgery department of Rangueil University hospital in Toulouse (France). All participants were informed about the study’s objective and provide written informed consent. Anonymity was maintained during patient inclusion.
Burn patients suffer a serious traumatic injury causing both esthetic-functional and psycho-social sequelae. In particular, severe burns lead to important psychological repercussions which consist in part in self-image, relationships and communication’s problems, that significantly deteriorate the quality of life of these patients. In addition, burn patients suffer from post-traumatic stress disorder [1] and they are subjected to long and constraining treatments (including psychiatric treatment [2]), which often lead to considerable difficulties in the returning to work [3,4]. Burn survivors show important family difficulties and bad social integration [5–7]. It is accepted that both psychological and physical consequences of burns account for mild to severe impairment and disability, and significantly affect health related quality of life (HRQoL) [8]. The quality of life (QoL) is still a recent concept even that its evaluation is in constant development. The World Health Organization (1994) defines ‘‘Quality of life as individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. It is a broad ranging concept affected in a complex way by the person’s physical health, psychological state, level of independence, social relationships, personal beliefs and their relationship to salient features of their environment’’. QoL evaluation is expressed through a multidisciplinary assessment, both qualitative and quantitative, and it is based on the exploration of different dimensions (physical, cognitive, and behavioral). In burned patients, QoL is often severely altered and this alteration depends very often on total body surface area involved and on the incriminated zone: burns at the hands and at the cephalic extremity level [9] are particularly implicated in problems of self-image and in alterations of own social role. QoL scales are extremely useful tools but unfortunately still not widely used in current clinical practice. In our opinion these types of scales have several functions: they are helpful both for patients to become more aware of their physical and mental state and to understand their needs and their progress, and both for physicians to understand if there is satisfaction or dissatisfaction of patients compared with their health state and, if so, proceed in the appropriate management. They can also be useful in terms of research, to establish for example a gold standard between different types of treatments.
1.2.
Aim of the study
The purpose of this present study is to propose the French translation of the BSHS-B and to present the results of a French validation project, assessing the internal consistency (reliability of the scales) by Cronbach’s alpha and the construct validity through correlations with the Short Form 36 Health Survey Questionnaire (SF-36). Through its translation and the possible cultural adaptation we could achieve a widely used validation in France and French speaking countries.
2.1.
Materials and methods
Study design
The study was conducted in two steps: translation and cultural adaptation at first, and cross-sectional validation at last.
2.2.
Sample
In order to test the reliability of the French version of the BSHSB, this questionnaire and the Short Form 36 Health Survey Questionnaire (SF-36) [10,11] were administered to a sample of 53 burn patients (66% males), from 18 to 70 years old, admitted at first to the Plastic Surgery and Burns Therapy ward (Centre Hospitalier Universitaire de Rangueil, Toulouse, France) from January 2007 to January 2012. We included patients presenting a percentage of total body surface area (TBSA) from 10% to 54%, all with deep burns (deep second degree and third degree). We excluded psychiatric and pediatric populations, patients who had undergone the burn for less than 2 years at the time of the study (healing process cannot be considered completed before this period), patients with a total body surface area (TBSA) <10% and suffering from superficial burns. The responders and the non-responders group were compared in terms of age, gender, and burn size. The two instruments were administered by the same plastic surgeon during hospital visits in a period of one year (from January 2014 to January 2015). In only one case the instrument was sent to the patient and sent back to the investigator by ordinary mail.
2.3.
Instruments
The instruments used to collect data for the health related quality of life of burn patients were the French version of the SF-36 questionnaire [11] and the BSHS-B questionnaire [12] that was translated to French (BSHS-F, see Appendix A).
2.3.1.
Short-Form 36 Health Survey (SF-36)
The Short Form 36 Health Survey Questionnaire (SF-36) is a scale built from the Medical Outcomes Study (MOS), used to measure the overall state of health and quality of life [10]. It consists of 36 items grouped into 8 main domains (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health). It has already been used to evaluate the quality of life in patients with burns [12] and it has shown its validity and reliability in French [11]. Actually, this 36-item questionnaire remains one of the most widely used measures of generic HRQoL assessments.
Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011
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2.3.2.
Burn Specific Health Scale-Brief (BSHS-B)
QoL of burn patients is assessed by the Burn Specific Health Scale (BSHS), developed in 1982 by the group of Baltimore Regional Burn Center in the United States [13] and initially consisted of 369 items, subsequently reduced to 114. The scale was then abbreviated into 80 items (The Abbreviated Burn Specific Health Scale – BSHS-A), measuring four major domains (Physical, Mental, Social, General). The scale was revised by Blalock et al. [14] (The Revised Burn Specific Health Scale – BSHS-R), resulting in 31 items. In this scale the exploration of hand function and sexuality were excluded. Finally, in 2001, a shorter but complete version was produced by Kildal et al.: the Burn Specific Health Scale-Brief (BSHS-B) [15]. This scale is the most cited in literature and is widely use in general practice: it is based on simple questions and it takes approximately 10–15 min to be completed. The Burn Specific Health Scale-Brief (BSHS-B) consists in 40 items grouped in nine sub-domains: simple abilities (3 items), hand function (5 items), work (4 items), body image (4 items), heat sensitivity (5 items), treatment regimens (5 items), affect (7 items), interpersonal relationships (4 items), and sexuality (3 items). Each item describes a particular task or experience that burn patients have to evaluate on a scale from 0 (extreme) to 4 (not at all). The nine sub-domains were built following Kildal et al. [15]. A recent factor analysis [8,16,17] showed that, with the exception of work, all the above sub-domains can be grouped into three major domains: the function domain (simple abilities and hand function), the skin sensitivity domain (body image, heat sensitivity, and treatment regimen), and the affect and relationship domain (affect, interpersonal relationship, and sexuality). Mean scores were calculated for each of the sub-domains, for the three majors domains, as well as the overall scale. Consistently with other HRQoL scales, lower scores of the BSHS correspond to a worse quality of life. BSHS has been used in several countries and has been translated and validated in Norwegian [18], Italian [19], Persian [20], Turkish [16], Chinese [8,21], Spanish [22] and Hebrew [23].
2.3.3.
BSHS-B translation procedure
According to the procedure proposed by the Scientific Advisory Committee of the Medical Outcomes Trust [12], three experienced independent interpreters translated the Burn Specific Health Scale-Brief (BSHS-B) from the English version into French language. The translation was then developed by consensus using a fourth expert. At second, we included a back translation from the common French version to English by an independent translation version written by a professional English translator. We then compared the translations to harmonize the final French translation. A simple transposition does not appear to be sufficient [10,24], and in this manner we tried to apply a cultural adaptation, according to the fact that the perception of quality of life in Latin countries can be quite different from that of the Anglo-Saxon countries, but no major differences were found.
2.4.
Data collection
101 eligible burn patients were initially approached by phone and invited to attend the study. 53 responders patients
3
received during a hospital visit the SF-36 and BSHS-B French version questionnaire. In order to avoid the ‘‘order effect’’ each questionnaire was randomly assigned by the same Plastic Surgeon (SG). In only one case both instruments were sent to the patient and sent back to the investigator by ordinary mail. Socio-demographic and clinical information was collected for every patient. Stability in time of the BSHS-B French version was evaluated using test–retest analysis [23,25,26] for 10 patients after 6 months from the first evaluation.
2.5.
Psychometric documentation
Reliability: the internal consistency of the French BSHS-B was assessed for each sub-domains and major domain, as well as for the overall scale. Construct validity: SF-36 was chosen as the gold standard measure for HRQoL and correlations with the French BSHS-B sub-domains were analyzed to assess the construct validity. Stability: the test–retest method was performed at 6 months to assess the stability of the French BSHS-B over the time.
2.6.
Statistics
All analyses were performed with the software R [27]. Subdomain’s scores of the BSHS-B questionnaire were computed as the percentage ratio between the sum of the scores of the relative items and the maximum score attainable for that subdomain. Results related to each sub-domain from the two instruments are reported in terms of mean, standard deviation and median. Categorical or nominal variables are presented as counts and percentages with 95% confidence interval. Construct validity is one of the most important measurement characteristic for a scale. In order to evaluate the construct validity, the literature recommends evaluating the relationship between similar constructs measurement scale [21]. Reliability of the French version of the BSHS-B questionnaire was assessed by Cronbach’s alpha measuring internal consistency, while construct validity was assessed by Spearman correlations with the domains of the SF-36 scale. It was considered acceptable when Cronbach’s-a value was above 0.7 [28]. Test–retest was assessed using a type C intra-class correlation coefficient (ICC) that was calculated using a twoway random effects model. We assessed the test–retest for the nine sub-domains. ICC is presented with 95% confidence interval and p value. ICC above 0.7 was considered appropriate for a good test–retest [29]. As performed in the Chinese BSHS-B, floor and ceiling effects may influence the reliability, validity and responsiveness of an instrument [8]. These effects would be considered present if >15% of the respondents achieved the highest or lowest possible score.
3.
Results
3.1.
Baseline characteristics
We admitted 385 patients during the years 2007–2012 in our burn therapy ward. Of these, 101 patients were eligible for
Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011
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participation. Ultimately, 53 patients were responders (52.47%) and 10 of these completed the questionnaire twice to attend the test–retest reliability (Fig. 1). The analyzed sample consisted of 53 patients, especially male patients (66% males), more often with suspended work after burn. The average age was approximately 46 years old (46.4 15.9); the total body surface area (TBSA) was approximately of 27% (26.9 15.9 [range: 10–54%]). Table 1 reports the characteristics of the studied sample. All subjects enrolled in the study completed the two questionnaires (SF-36 and BSHS-B French version) and the interval between the burn and the QoL evaluation was 24–60 months. Test–retest group burn to questionnaire time interval was at least 6 months. Table 2 reports mean and median values in each domain for the SF-36 scale.
3.2.
Response bias analysis
There were no difference in terms of age, sex, and burn size between the responders and the non-responders ( p > 0.05).
3.3.
BSHS-B French version
Reliability: internal consistency was calculated for the whole instrument, and separately for the nine sub-domains using Cronbach’s alpha value. For all sub-domains Cronbach’s alpha resulted equal to or larger than 0.8, with the highest level for 5 sub-domains (Affect, Hand Function, Treatment Regimens, Work, Sexuality) and for the whole instrument (total score for alpha value was 0.93) (Table 3). Validity: construct validity was investigated through correlation with the SF-36 questionnaire. Table 4 reports Spearman correlations along with the relative p values, and shows SF-36’s domains that have been included in the major domains of the BSHS-F. All the correlations were found statistically significant ( p < 0.01) with Spearman’s coefficient ranging from 0.3 to 0.9. Stability: intra-class correlation coefficients for test–retest ranged between 0.95 and 0.98 (Table 5). The intra-class correlation coefficient (ICC) for the total score was 0.98. There were no differences in terms of age, sex, and burn size between tests and the re-tests participants ( p < 0.05).
Table 1 – Demographic data of burn patients (N = 53). Age (mean SD) Gender, N (%) Female Male TBSA, % (mean SD) Mild burn, N (%) Moderate burn, N (%) Severe burn, N (%) Burn localization, N (%) Cephalic area Upper limb Hands Lower limb Chest Abdomen Dorsal region Perineum Etiology of burn, N (%) Hot water Flames Explosion of gas Hot oil Suicide attempt Others Activity, N (%) Unemployed Worker Part-time worker Retired Suspended Student
46.4 15.9 18 (34) 35 (66) 26.9 15.9 13 (24.5) 19 (35.8) 21 (39.6) 27 18 18 13 26 11 10 1
(50.9) (33.9) (33.9) (24.5) (49.0) (20.7) (18.9) (1.8)
13 10 8 5 4 13
(24.5) (18.8) (15.0) (9.4) (7.5) (24.5)
5 9 1 11 20 7
(9.4) (17.4) (1.9) (20.8) (37.7) (13.2)
Feasibility and clarity assessment: the completion time of BSHS-B French version questionnaire was 11 min in average (range: 9–14 min). Floor and ceiling effects: neither floor effects (indicating worst possible score) nor ceiling effects (indicating best possible score) were found for the three majors domains.
4.
Discussion
No French validation of the BSHS-B was so far available in the literature. In this sense, we wanted to provide the French version of the BSHS-B widely exploitable to evaluate the HrQoL
Fig. 1 – Demographic data of burn population between 2007 and 2012 in our burn center.
Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011
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Table 2 – Domain average scores of the SF 36.
Physical Functioning Role-Physical Bodily Pain General Health Social Functioning Mental Health Role-Emotional Vitality
Mean
SD
Median
67.5 22.6 61.7 63.1 61.3 46.8 42.1 39.4
23.1 29.5 19.5 16.2 29.7 19 40.4 19
70 0 62 72 62.5 48 33.3 35
of burn patients in French population and in French-speaking countries. The completion time of 11 min on average was very satisfactory and compatible with its use in routine clinical practice. All patients considered that the French version of BSHS-B was quite easy to read and understand, which is a crucial element for a correct QoL evaluation. We highlighted a good internal consistency of the French BSHS-B with 0.93 concerning the total score of the Cronbach’s alpha coefficients and above 0.8 for the three major domains. The overall scale coefficient appears close to previously published studies on this subject as Chinese (0.97), Hebrew (0.97), Persian (0.95), or Italian (0.89). Reliability of the French BSHS-B was very satisfying as no sub-domains were lower than 0.7 as recommended (0.78–0.93), similarly to the original study of Kildal and other translations of the BSHS-B available in literature [8,15–23]. Cronbach’s alpha values resulted equal to or larger than 0.8, with highest levels for five sub-domains (Affect, Hand Function, Treatment Regimens, Work, Sexuality) and for the whole instrument (>0.9), suggesting an excellent rate for internal consistency [30]. Lower values results, but close to 0.8, were found in the Heat Sensitivity sub-domain (where no correlations are found between the two scales), and the Interpersonal Relationships subdomain. Construct validity was investigated through correlations with the generic instrument SF-36. For the SF-36 the lowest average score was observed for the ‘‘Physical Role’’ domain (mean 22.6), which describes the aspects related to the
Table 3 – Domain average scores of the BSHS-B questionnaire along with p values and Cronbach alpha. Cronbach alpha Function domain Simple abilities Hand function Skin involvement domain Heat sensitivity Treatment regimens Body image Affect and relationship domain Sexuality Interpersonal relationship Affect Work Total score
0.79 0.83 0.78 0.9 0.79 0.81 0.78 0.93 0.89 0.93
Table 4 – Correlations (Spearman) between BSHS-B and SF-36. BSHS-B
SF-36
Spearman’s rho
p
Heat sensitivity
No correlations
–
Affect
Role-Physical General Health Social Functioning Mental Health Role-Emotional Vitality
0.4 0.7 0.8 0.9 0.8 0.8
0.006 <0.001 <0.001 <0.001 <0.001 <0.001
–
Hand function
Physical Functioning Role-Physical Bodily Pain General Health Vitality
0.8 0.4 0.7 0.4 0.3
<0.001 <0.001 <0.001 0.004 0.015
Treatment regimens
General Health
0.4
0.008
Social Functioning Mental Health Role-Emotional Vitality
0.4 0.7 0.5 0.5
0.001 <0.001 <0.001 <0.001
Work
Role-Physical Social Functioning Role-Emotional
0.6 0.3 0.4
<0.001 0.029 0.001
Sexuality
Bodily Pain General Health Social Functioning Mental Health Role-Emotional Vitality
0.3 0.6 0.6 0.6 0.6 0.6
0.019 <0.001 <0.001 <0.001 <0.001 <0.001
Interpersonal relationship
General Health
0.5
<0.001
Social Functioning Mental Health Role-Emotional Vitality
0.8 0.8 0.6 0.6
<0.001 <0.001 <0.001 <0.001
Simple abilities
Physical Functioning Role-Physical Bodily Pain General Health Mental Health Role-Emotional Vitality
0.7 0.4 0.7 0.5 0.3 0.4 0.6
<0.001 0.002 <0.001 <0.001 0.015 0.007 <0.001
Body image
General Health Social Functioning Mental Health Role-Emotional Vitality
0.5 0.7 0.7 0.6 0.5
<0.001 <0.001 <0.001 <0.001 <0.001
limitation of the time dedicated to work as well as to the difficulty in carrying out work-related activities. This correlates with the fact that most of the patients, in the sample studied, have suspended their work after the occurred burn or sequentially to treatments carried them out. The French version of BSHS-B (BSHS-F), exhibits positive correlations with SF-36, showing good construct validity. Highest correlations were found between Mental Health of the SF-36 and Affect of the BSHS-F, Physical Functioning of the SF-36 and Hand Functioning of the BSHS-F, Social Functioning of the SF-36 and Interpersonal Relationships of the BSHS-F.
Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011
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Table 5 – Test–retest reliability of the BSHS-B questionnaire (n = 10). First score
Second score
ICC
Confidence interval 95%
p value
Mean
SD
Mean
SD
Heat sensitivity Affect Hand function Treatment regimens Work Sexuality Interpersonal relationship Simple abilities Body image
11.8 15.3 16.1 10 8.4 6 13.7 10.2 7.5
2.78 6.86 4.41 5.56 3.50 2.66 2.98 2.04 2.88
11.8 16.3 16.6 10 8.9 6.6 13.7 10.1 8
3.04 6.96 4.01 5.29 3.35 2.86 2.87 2.08 3.16
0.99 0.98 0.97 0.97 0.96 0.96 0.99 0.96 0.95
0.91–1 0.81–1 0.88–0.99 0.89–0.99 0.95–1 0.54–0.99 0.96–1 0.87–0.99 0.74–0.99
<0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
Total score
99
3.50
3.55
0.98
0.84–1
<0.001
102
Correlation’s analysis of these two instruments (SF-36 and BSHS-F) showed that the deterioration of physical function and social relations leads to significantly affect the overall quality of life in our sample of patients, the scores being lower in these domains. These two aspects (physical dysfunction and loss of social relations), may be consequential, indeed in most cases physical dysfunctions related to post-burn sequelae determine suspension of work and common activities by patients, resulting in fewer opportunities for social gatherings. Test–retest reliability is a reflection of the stability of a questionnaire in a defined period of time and has been successfully used in the Hebrew translation of the BSHS-B by Stavrou et al. [19,26]. In our study, patients have been re-tested at least at 6 months and the BSHS-F showed high ICC values ranging from 0.95 to 0.99, demonstrating a good stability in time. The total score ICC was 0.98. Similar results were found in previous studies for validation of the Persian version and the Hebrew version [20,23]. Some limitations of this study relate to the small sample of patients (n = 53) in only one Burn unit and the test–retest analysis was conducted on a relatively small sample size (n = 10). Nonetheless, the excellent results in terms of internal consistency, construct validity and stability in time, are encouraging and prelude to the use of the BSHS-B French version at first, at national level, then in international studies.
5.
Conclusion
Our French version of the BSHS-B shows a good rate of internal consistency, construct validity and stability in time supporting its application in routine clinical practice and lays the groundwork to a multicenter French validation study. Through this version, French-speaking countries will be able to make use of the BSHS-B to evaluate the health related quality of life of burn patients. We need to focus on the fact that the use of quality of life scales has to become routine in medical practice, especially in burn patients who require a multidisciplinary management, as well as a long-term followup.
Conflict of interest All authors do not have any financial and personal relationships with other people or organizations that could inappropriately influence their work.
Acknowledgement The study was not funded by any external source.
Appendix A. French version of the Burn Specific Health Scale-Brief (BSHS-F) il s’agit d’un score pour l’e´valuation de la qualite´ de vie du patient brule´, il requiert 10 a` 15 minutes. Il est comple`tement anonyme. Ces informations nous permettront de mieux savoir comment vous vous sentez dans votre vie de tous les jours. Veuillez re´pondre a` toutes les questions en entourant le chiffre correspondant a` la re´ponse choisie. Si vous n’eˆtes pas certain de votre re´ponse, choisissez la re´ponse la plus proche de votre situation.
1. 2. 3.
Avez-vous des difficulte´s a`? ` vous laver de fac¸on autonome? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2 Un peu = 3; Aucune (Absolument pas) = 4 ` vous habiller vous-meˆme? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4 ` vous asseoir et a` vous lever d’une chaise? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4
Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011
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4. 5. 6. 7. 8. 9.
10. 11. 12. 13. 14. 15.
16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34.
` signer? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ ` manger avec des couverts? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ ` lacer vos chaussures? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ ` attraper des pie`ces de monnaie au sol? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ ` de´verrouiller une serrure? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ ` effectuer votre ancien me´tier? A Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´
(ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4 (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4 (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4 (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4 (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4 (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4
Dans quelle mesure chacun des e´nonce´s suivants vous correspond? Je suis envahi par un sentiment de solitude Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Jamais (Absolument pas) = 4 Souvent je me sens triste ou avec une humeur de´pressive Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Jamais (Absolument pas) = 4 A certains moments, j’ai des proble`mes e´motionnels Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Jamais (Absolument pas) = 4 Je n’ai pas envie de faire des activite´s avec mes amis Jamais envie = 0; rarement envie = 1; Mode´re´ (ment) envie = 2; assez souvent envie = 3; tre`s souvent envie = 4 Je n’aime plus rendre visite a` mes connaissances Plus du tout = 0; beaucoup moins = 1; Mode´re´ (ment) = 2; Un peu moins = 3; Si, comme avant = 4 Je n’ai personne avec qui parler de mes proble`mes Absolument personne = 0; de rares personnes = 1; Quelques personnes = 2; Beaucoup de personnes = 3; Enorme´ment de personnes = 4 J’ai l’impression d’eˆtre pie´ge´ ou la sensation d’eˆtre emprisonne´ Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Aucune (Absolument pas) = 4 Mes brulures m’ont e´loigne´ de ma famille Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Je pre´fe`re eˆtre seul qu’avec ma famille Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Je n’aime pas la fac¸on dont ma famille agit autour de moi Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Ma famille serait mieux sans moi Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Je me sens frustre´ parce que je n’ai pas retrouve´ ma libido d’avant Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Clairement, je ne suis plus inte´resse´ par le sexe comme avant Plus du tout = 0; beaucoup moins = 1; Mode´re´ (ment) = 2; Un peu moins = 3; Si, comme avant = 4 Je n’embrasse plus, ou je n’e´treins plus comme avant Plus du tout = 0; beaucoup moins = 1; Mode´re´ (ment) = 2; Un peu moins = 3; Si, comme avant = 4 Parfois, je souhaiterais oublier avoir change´ d’aspect Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Je sens que ma brulure de´range les autres Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Mon aspect en ge´ne´ral m’est de´sagre´able Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 L’aspect des mes cicatrices me ge`ne Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Etre au soleil me de´range Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Les chaudes conditions climatiques me de´rangent Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Je n’arrive pas a` sortir ou faire des choses quand il fait chaud Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Ne pas pouvoir sortir quand il y a du soleil me de´range Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Ma peau est plus sensible qu’avant Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Soigner ma peau est pe´nible Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument pas = 4 Je n’aime pas faire les soins qui m’ont e´te´ conseille´s pour mes bruˆlures Je n’aime extreˆme(ment) pas = 0; J’aime peu les faire = 1; Mode´re´ (ment) = 2; c¸a` me geˆne peu = 3; c¸a ne me geˆne pas du tout = 4
Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011
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35. 36.
37.
38. 39. 40.
Je pre´fe´rerais n’avoir rien a` faire pour le soin des mes bruˆlures Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un peu = 3; Absolument J’ai du mal a` faire toutes les choses conseille´es pour le soin des mes bruˆlures Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un Peu = 3; Absolument En prenant soin de mes bruˆlures, il m’est difficile de faire d’autres choses importantes pour moi Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un Peu = 3; Absolument Ma bruˆlures interfe`re avec mon travail Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un Peu = 3; Absolument Etre brule´ a affecte´ ma capacite´ a` travailler Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un Peu = 3; Absolument Ma bruˆlures a engendre´ des proble`mes dans mon travail Extreˆme(ment) = 0; Beaucoup = 1; Mode´re´ (ment) = 2; Un Peu = 3; Absolument
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pas = 4
pas = 4
pas = 4 pas = 4 pas = 4 pas = 4
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Please cite this article in press as: Gandolfi S, et al. Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire. Burns (2016), http://dx.doi.org/10.1016/j.burns.2016.04.011