Doris Hexsel1, Magda Blessmann Weber1, Maria Laura Taborda1, Taciana Dal'Forno1, Débora Zechmeister-Prado1
Keywords: QUALITY OF LIFE, QUESTIONNAIRES, CELLULITIS
The World Health Organization supports an inclusive view of health, according to which the state of b eing healthy does not refer merely to a lack of a disorder or illness, but also an individual''''''''s ability to lead a productive and pleasant life. 1 Although important, evaluating quality of life is neither an easy nor a simple task. As a result, several measure- ments that apply to several disorders or groups of patients have been de veloped and validated. 2,3
Dermatology and other medical specialties – such as plastic surgery – involve caring for patients with aes thetic complaints. However, there is comparatively little discussion in the literature of quality of life in this area.
Cellulite is a condition that occurs mostly in women, affecting especially the thighs and buttocks, and constitutes an extremely frequent complaint. The term, which originated in the French medical literature more than 150 years ago, is glob- ally known and used to characterize alterations on the skin''''''''s sur- face that resemble the appearance of an orange peel, cottage cheese or a quilt. Synonyms include: edematous adi posity and gynoid lipodystrophy.
Although its prevalence has not been established, most women develop some degree of cellulite following puberty. It is prevalent in women of all races, but is more common in Caucasians. 4 There are three hy potheses that try to explain cellulite''''''''s physiology: inflammatory factors and vascular or con- junctive tissue''''''''s septae alterations; 4 there is also a relevant hor- monal component, since it affects almost all women and is rare in men. The first classification of cellulite was described by Nurnberger and Muller in 1978 and was based on the lesions'''''''' clinical aspect. 5 A new classification developed by Dal''''''''Forno and Hexsel – the Cellulite Severity Scale – adds further clinical parameters,, evaluating cellulite qualitatively and quantitatively.6
There is an increasing search for a perfect physical appear- ance, and a lack of clinical studies in this field.
In Brazil, the rates of plastic surgeries and cosmetic con- sultations are among the highest in the world. Understanding the reasons that lead patients to undergo such a great number of procedures – including surgeries – to improve their physical appearance could lead to a decrease in the current number of unnecessary procedures. 7,8 The accelerated growth of dermato- logic consultations about aesthetic complaints suggests there is a need for a more inclusive understanding of the characteristics, desires and expectations of patients that seek cosmetic proce- dures.
Noting the lack of a method to evaluate the quality of life in patients with cellulite, the authors were motivated to devel- op such an instrument to make it possible to verify, both quan- titatively and qualitatively, the reasons why aesthetic imperfec- tions are considered an inconvenience that disturb and interfere with people''''''''s daily life, apparently more intensively today than in previous times.
This study is aimed at the elaboration and validation of an instrument for evaluating of the quality of life of patients with cellulite.
A transversal study was developed to analyze female patients aged 18 or older who sought treatment for cellulite at the research unit of the Centro Brasileiro de Estudos em Dermatologia – Brazilian Center of Studies in Dermatology (CBED in Porto Alegre, RS, Brazil. Patients with a history of psychiatric disorders or decompensated systemic disorders such as systemic arterial hypertension and diabetes mellitus, were excluded.
The study was conducted according to Good Clinical Practices and the Declaration of Helsinki. The research study was approved by the ethics committee of the Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA) and was assigned the number 281/06.
The study comprised two stages, each of which had two phases: the preparation and validation of a Portuguese-language assessment tool and the evaluation of patients'''''''' quality of life.
Stage I: Preparation of the quality of life evaluation tool Based on information contained in the CBED''''''''s research unit database, patients who had already sought care relating to cellulite were identified and invited to participate in the study as a convenience sample. The sample used in that stage of the study was based on convenience, having been considered ideal when there was enough coincidence of answers, without the presence of new significant complaints. The patients were eval- uated in light of the inclusion and exclusion criteria before the interview. Those who were eligible for participation were instructed about the objectives of the analysis and offered a Term of Free and Informed Consent to be signed in case of agreement. The patients took part in the study by answering a single open-ended question about which aspects of their lives are impaired by their cellulite: "We are trying to find out how much cellulite affects the patients'''''''' life. We would be grateful to have your help, though you are not obliged to do so. Please describe below how cellulite affects your life. You can take into consideration any aspect of your professional and social life, per- sonal relationships, leisure activities, or any other situation. Although it would be important to know your age, you don''''''''t need to disclose it."
In the second phase of Stage I, patients'''''''' answers were qual- itatively assessed and a database with the main complaints, grouped in wider domains, was created as described below:
Manner of dressing: choices of colors and fabrics, choice of tighter cuts and use of very short clothes.
Leisure: participation in group activities that involve expos- ing the body to a large number of people (beach, swimming pool) or a more restricted number of people (massage).
Physical activities: participation in sports activities that require exposing the body (swimming, water aerobics).
Partner: exposing the body to a partner, fear of losing the partner, restrictions in sexual life, bothered by the fact that a partner notices the cellulite.
Feelings: embarrassment, difficulties and doubts about the result of treatments, disbelief, guilt, frustration, discouragement, decrease in self-esteem, rebelliousness.
Changes in daily habits: changes in eating habits, spending more than able to afford on medications and creams, restricting other expenses to treat cellulite.
The results of this analysis also allowed the preparation of an initial questionnaire to assess the quality of life of patients who complained about cellulite.
Stage II: Questionnaire preparation and validation
With the identification of the domains and main points
referred to in each of them, the initial version of Celluqol
® was
developed. The initial phase of Stage II included all questions
(22 in total, Table 1) in order to validate those that would con-
stitute the final questionnaire. A shortened 8-item version was
developed (Table 2) and compared with the full version, to
explore its use in daily medical practice.
The scores obtained from the full questionnaire ranged from 22 to 110 points, with the measured changes in quality of life assessed as follows:
From 22 to 44 points – cellulite does not affect quality of life
From 44 to 66 points – cellulite slightly affects quality of life
From 66 to 88 points – cellulite reasonably affects quality of life
From 88 to 110 points – cellulite intensely affects quality of life
The shortened questionnaire''''''''s scores ranged from 8 to 40 points, with changes in quality of life interpreted as follows:
From 8 to 16 points – cellulite does not affect quality of life
From 16 to 24 points – cellulite slightly affects quality of life
From 24 to 32 points – cellulite reasonably affects quality of life
From 32 to 40 points – cellulite intensely affects quality of life
After administering the full and shortened versions of the questionnaires to 100 volunteers, their validity and reliability were assessed using Cronbach''''''''s factorial and Alpha analyses for statistical evaluations.
An exploratory factorial analysis allowed testing of the hypotheses that all eight questions of the shortened question- naire measured a single domain or factor (cellulite) and that each block of questions in the full questionnaire measured a sin- gle domain or factor of the appraised parameters (manner of dressing, leisure, physical activity, partner, feelings and change of daily habits). A factor was considered dominant if its measured eigenvalues were greater than 1. A component of the matrix of a domain was considered to belong in the factor or domain when its weight was greater than 0.4.
In the evaluation of the shortened questionnaire, it was observed that only one could be deemed the main component, when the greater than 1 eigenvalues criterion was considered. The explained variance was 48.77%, and Cronbach''''''''s Alpha, 0.842 (Table 3). The factorial analysis of the full version of the questionnaire presented five main components when the greater than 1 eigenvalues criterion was considered. The explained vari- ance was 70.72%, and Cronbach''''''''s Alpha was 0.935 (Table 4).
Since no information was found about previous studies that have validated a specific questionnaire assessing the quality of life for patients with cellulite, it was unfeasible to forecast the variability of answers in the present study. A sample calculation to estimate a proportion was therefore carried out, maximizing the variance and considering a 95% confidence interval. This sample calculation supplied the estimate of 385 patients. Nevertheless the study was conducted with 100 patients. A pre- liminary analysis was subsequently performed to analyze the behavior of the data and the necessity of including a greater number of patients. As the data showed considerable consisten- cy, it was not necessary to increase the sample size.
The factorial analysis of the shortened questionnaire found that each question measured a single factor or domain: cellulite. This single domain explains 48.77% of the variance, indicating that all questions in the shortened questionnaire effectively refer to cellulite. Since each matrix component presented expressive values, it was not necessary to exclude any questions. In addi- tion, the Cronbach''''''''s Alpha (0.842) indicated good internal con- sistency for the shortened questionnaire (Table 2).
The factorial analysis of the full version of the question- naire indicated that those questions measured five main factors or domains. Observing the matrix components, it was verified that all questions corresponding to the "manner of dressing" appeared together in the same domain with expressive values (Table 3). The questions regarding "leisure" and "physical activ- ity" appeared together in the same domain, suggesting that they measure the same parameters. Of the questions considered, it was found that QB3a and QB4b could probably be combined into a single question due to their similarity, with the variables being grouped in a single domain (i.e., without differentiating between leisure and physical activity). All questions regarding the "partner" appeared in the same domain, indicating that they are in accordance with the questionnaire – as well as all ques- tions regarding "changes in daily habits." The variables relating to "feelings" were generally consistent, appearing in different domains, except for QB5a and QB5b, which were the least expressive and did not appear in the same domain as the others, suggesting they could be modified or excluded. The 0.935 Cronbach''''''''s Alpha indicated good internal consistency in the full version of the questionnaire.
The questionnaire was easy to administer, and the patients did not have difficulty in understanding the questions. The aver- age time of application was five minutes – rather reasonable for clinical use and research.
Comparisons of Celluqol with other quality of life ques- tionnaires should be carried out in the future to assess the cor- relation of quality of life changes in patients with cellulite with that of patients in general.
The authors developed two questionnaires to evaluate the quality of life in female patients with cellulite. Administration of the measurement was straightforward, and the validation analy- ses demonstrated that both questionnaires could be used with similar efficacy. In daily clinic practice, the shortened version is recommended to evaluate cellulite as the main component of changes in patients'''''''' quality of life. The full version of the ques- tionnaire presented five main components for evaluating patient quality of life; its use is recommended for clinical research.
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