The Melasma Quality of Life scale (MELASQOL) is a useful tool in assessing quality of life in patients with melasma. Initially developed in English, it has recently been translated into Spanish, Brazilian Portuguese, French, and Turkish. Development of a validated, translated, disease-specific quality of life questionnaire is a complex process which is further discussed in this article. When developing the MELASQOL in other languages, careful attention must be paid to cross-cultural adaptation and proper methods of translation and validation to have an accurate instrument. This article addresses these methods, which could be useful to those desiring to develop the MELASQOL in other languages.
Over the last 2 decades, multiple studies have demonstrated that skin diseases cause substantial physical and psychosocial distress. Assessing quality of life (QOL) is important in determining a treatment plan and its efficacy, particularly because health status may not correlate with severity of disease. In the 1990s, QOL measures specific to dermatology, such as the Skindex and Dermatology Life Quality Index (DLQI), began to emerge, which documented the significant impact skin diseases can have on patients’ QOL. More recently, QOL questionnaires specific for skin diseases have been developed because of their ability to more accurately assess a patient with a particular skin condition, such as the Cardiff Acne Disability Index, Psoriasis Disability Index, Quality of Life Index for Atopic Dermatitis, Chronic Urticaria Quality of Life Questionnaire, and Melasma Quality of Life scale (MELASQOL).
The MELASQOL is a useful tool because melasma is asymptomatic but disfiguring, often leading to a significant effect on QOL. Although initially developed in English, it has recently been translated into Spanish, Brazilian Portuguese, French, and Turkish. Development of a validated, translated, disease-specific QOL questionnaire is a complex process that is further discussed. Because melasma is a worldwide problem, it is important to develop the MELASQOL in other languages, although careful attention must be paid to cross-cultural adaptation and proper methods of translation to have an accurate tool. This article addresses these methods that could be useful to those desiring to develop the MELASQOL in other languages.
Melasma
Melasma is a common disorder of acquired hyperpigmentation characterized by tan or brown macules and patches localized to photo-exposed areas of the face, particularly the malar areas, forehead, and chin. Melasma affects 8.8% of Latino women and is more prevalent in women, with men comprising about 10% of all cases. Melasma affects all races but is especially prevalent in those with darker skin types (Fitzpatrick skin types III to VI) and has been highly reported in patients of Hispanic, African American, Arab, South Asian, Southeast Asian, and East Asian descent. The exact cause of melasma is unclear, but factors include genetic predisposition, ultraviolet light exposure, pregnancy, oral contraceptives, hormone replacement therapy, thyroid disease, cosmetics, and medications. The lesions are usually asymptomatic but often have considerable emotional and psychological effects. The Melasma Area and Severity Index (MASI) is used to reliably measure the clinical severity of melasma and monitor changes after therapy. However, the QOL of patients with melasma does not correlate well with the MASI score. Hence, the psychological impact of melasma, with its disfiguring facial discoloration and chronic nature, has profound negative effects on patients’ QOL, which is not captured by the MASI. In order to illustrate the full impact of melasma on a patient’s life, several QOL instruments have been developed to address the various life domains that can be affected because of the presence of this disorder.
QOL instruments
Generic QOL measures, such as the internationally used 100-item World Health Organization Quality of Life Instrument (WHOQOL) and its abbreviated version, the 26-item WHOQOL-BREF, allow for comparison of health-related QOLs across all diseases. Like other nonspecific health-related QOL questionnaires, the WHOQOL-BREF can be used in a broad spectrum of patients, from those with hypertension to psoriasis to chronic obstructive pulmonary disease (COPD). To be applicable to such a diverse population, the WHOQOL-BREF covers several facets of life and equally weighs each of its items. For example, the instrument evaluates the physical life domain by assessing factors such as physical pain and mobility and their effects on daily life activities. For a patient with COPD, the disease often causes profound physical pain and decreased mobility, which negatively affect the physical aspect of QOL. However, psoriasis predominantly affects the skin, causing pruritus, scaling, bleeding, and infection, which typically do not cause the same type of restrictive physical symptoms that can detract from activities of daily life. These psoriasis-specific symptoms are disregarded in most of the WHOQOL-BREF items concerning physical QOL. Therefore, the WHOQOL-BREF, like other general health-related QOL questionnaires, fails to address many aspects of skin diseases even though the impact psoriasis has on QOL is comparable to heart disease, prompting the development of more suitable dermatology-specific questionnaires.
Skin diseases have been shown to affect QOL to a similar extent as other chronic diseases. In children, generalized atopic dermatitis causes more QOL impairment than renal disease, cystic fibrosis, and asthma, and the effects of psoriasis and urticaria on QOL are worse than diabetes and epilepsy. Adult psoriasis has been found to be more detrimental to QOL than angina and hypertension. One study even determined that psoriasis caused worse physical and mental QOL than arthritis, cancer, myocardial infarction, and type II diabetes. These findings further emphasize the importance of developing more accurate QOL tools for dermatologic conditions.
In 1994, Finlay and Khan developed the DLQI, and Chren and colleagues introduced the Skindex in 1996 and later the condensed Skindex-16, both a great improvement from general health-related QOL questionnaires. For example, the Skindex-16 measures many aspects relevant to skin disease, including itching, burning or stinging, pain, irritation, persistence/recurrence, appearance, frustration, embarrassment, and depression. However, the disease-specific Psoriasis Disability Index goes into more detail than the DLQI and Skindex by asking patients about their frequency of changing or washing clothes because of psoriasis, frequency of bathing due to psoriasis, and problems with psoriasis at the hairdresser. Twenty-five percent of the Skindex-16 items concern physical symptoms, with the remaining 75% focusing on emotions and functioning, yet most patients with melasma do not experience any physical distress. Today, there is a recognized need for QOL instruments that weigh the various life domains differently based on the unique features of a specific skin disease, as evidenced by the number of disease-specific QOL questionnaires available.
QOL instruments
Generic QOL measures, such as the internationally used 100-item World Health Organization Quality of Life Instrument (WHOQOL) and its abbreviated version, the 26-item WHOQOL-BREF, allow for comparison of health-related QOLs across all diseases. Like other nonspecific health-related QOL questionnaires, the WHOQOL-BREF can be used in a broad spectrum of patients, from those with hypertension to psoriasis to chronic obstructive pulmonary disease (COPD). To be applicable to such a diverse population, the WHOQOL-BREF covers several facets of life and equally weighs each of its items. For example, the instrument evaluates the physical life domain by assessing factors such as physical pain and mobility and their effects on daily life activities. For a patient with COPD, the disease often causes profound physical pain and decreased mobility, which negatively affect the physical aspect of QOL. However, psoriasis predominantly affects the skin, causing pruritus, scaling, bleeding, and infection, which typically do not cause the same type of restrictive physical symptoms that can detract from activities of daily life. These psoriasis-specific symptoms are disregarded in most of the WHOQOL-BREF items concerning physical QOL. Therefore, the WHOQOL-BREF, like other general health-related QOL questionnaires, fails to address many aspects of skin diseases even though the impact psoriasis has on QOL is comparable to heart disease, prompting the development of more suitable dermatology-specific questionnaires.
Skin diseases have been shown to affect QOL to a similar extent as other chronic diseases. In children, generalized atopic dermatitis causes more QOL impairment than renal disease, cystic fibrosis, and asthma, and the effects of psoriasis and urticaria on QOL are worse than diabetes and epilepsy. Adult psoriasis has been found to be more detrimental to QOL than angina and hypertension. One study even determined that psoriasis caused worse physical and mental QOL than arthritis, cancer, myocardial infarction, and type II diabetes. These findings further emphasize the importance of developing more accurate QOL tools for dermatologic conditions.
In 1994, Finlay and Khan developed the DLQI, and Chren and colleagues introduced the Skindex in 1996 and later the condensed Skindex-16, both a great improvement from general health-related QOL questionnaires. For example, the Skindex-16 measures many aspects relevant to skin disease, including itching, burning or stinging, pain, irritation, persistence/recurrence, appearance, frustration, embarrassment, and depression. However, the disease-specific Psoriasis Disability Index goes into more detail than the DLQI and Skindex by asking patients about their frequency of changing or washing clothes because of psoriasis, frequency of bathing due to psoriasis, and problems with psoriasis at the hairdresser. Twenty-five percent of the Skindex-16 items concern physical symptoms, with the remaining 75% focusing on emotions and functioning, yet most patients with melasma do not experience any physical distress. Today, there is a recognized need for QOL instruments that weigh the various life domains differently based on the unique features of a specific skin disease, as evidenced by the number of disease-specific QOL questionnaires available.
MELASQOL
Balkrishnan and colleagues observed that little published information was available regarding the impact of melasma on daily life activities. In a pilot study of 50 women, melasma was associated with a significant impact on health-related QOL, with the strongest predictors of decreased QOL being increased disease severity, increased fear of negative evaluation, better perception of QOL without melasma, and lack of presence of concurrent rosacea or acne. Because of easy visible detection of melasma and its frustrating and often unsuccessful treatment, the investigators concluded that melasma had an undeniably greater psychosocial impact on QOL that needed to be explored and weighed more heavily in QOL instruments. Therefore, they sought to develop a QOL instrument for patients with melasma that accounted for the unique impact of the facial lesions on the psychological and social well-being of the individual while ignoring physical symptoms. To that end, the investigators devised the original MELASQOL in English to address the inadequacy of generic and dermatology QOL instruments for evaluating melasma. They randomly recruited 102 women by flyers or by referral from the Wake Forest University School of Medicine Dermatology Clinic in North Carolina. Women were eligible if they were older than 18 years, younger than 65 years, diagnosed with melasma by an investigator, and were able to complete the questionnaires. The investigators rated their melasma using the MASI instrument, and patients completed the Skindex-16, DLQI, a 7-item skin discoloration impact questionnaire created specifically for the study, and a 12-item Fear of Negative Evaluation questionnaire. The women also rated their perceived QOL on 8 aspects of their life with melasma and what they predicted it would be if they did not have melasma. Collection of these anonymous surveys in addition to patients’ demographics and health practices occurred in 1 visit.
Balkrishnan and colleagues chose 7 items from the Skindex-16 and 3 items from the skin discoloration questionnaire to form the new MELASQOL in an attempt to remove questions that had little correlation with melasma-specific health-related QOL, such as those concerned with physical discomfort. Items with the highest correlations with both Skindex-16 and the skin discoloration questionnaire were selected. The final 10-item questionnaire uses a Likert scale of 1 to 7 in which 1 signifies not bothered at all and 7 signifies bothered all the time (see Box 1 ). MELASQOL scores range from 7 to 70, a higher score signifying worse QOL. The mean MELASQOL score was 36, and the mean age was 39.7 years. Women in the 20- to 30-year age group had a significantly higher MELASQOL mean of 50.4 than other age groups. The questionnaire had a Cronbach α value of 0.95, reflecting very high internal consistency. Cronbach α is a coefficient of reliability used to assess the internal consistency of a psychometric scale, and a level greater than 0.70 is considered satisfactory. Furthermore, the MELASQOL correlated highly with the Skindex-16, DLQI, and skin discoloration questionnaire.
On a scale of 1 (not bothered at all) to 7 (bothered all the time), the patient rates how she feels about:
- 1.
The appearance of your skin condition
- 2.
Frustration about your skin condition
- 3.
Embarrassment about your skin condition
- 4.
Feeling depressed about your skin condition
- 5.
The effects of your skin condition on your interactions with other people (eg, interactions with family, friends, close relationship, and so forth.)
- 6.
The effects of your skin condition on your desire to be with people
- 7.
Your skin condition making it hard to show affection
- 8.
Skin discoloration making you feel unattractive to others
- 9.
Skin discoloration making you feel less vital or productive
- 10.
Skin discoloration affecting your sense of freedom
All MELASQOLs are scored from 7 to 70, with a higher score indicating worse melasma-related health-related QOL.
Like the DLQI and Skindex-16, the MELASQOL only moderately correlated with the MASI, further demonstrating how melasma’s impact on life quality is not merely based on disease severity. The MELASQOL discriminated better than the Skindex-16 among women with and without a history of psychiatric, psychological, or emotional problems. The new scale paralleled the Skindex-16, which was superior to the DLQI in discriminating among patient groups being treated with depigmenting creams or other methods or not being treated at all. The QOL domains most associated with lower QOL and higher MELASQOL scores, such as social life, leisure and recreation, and emotional well-being, were the same aspects patients perceived would improve the most if they were disease-free. The study was limited by the demographics of the patient population surrounding the academic medical center because most women were white married, and had at least a college education. As stated earlier, many patients with melasma do not fit into this demographic. Investigators acknowledged it would be beneficial to assess the discriminatory ability of the MELASQOL in monitoring improvement in QOL across different treatments. Overall, the MELASQOL is a valid objective instrument for measuring melasma’s influence on QOL in the American English-speaking population.
To investigate the impact of treatment on QOL in patients with melasma and to evaluate the efficacy and safety of a triple combination cream combining fluocinolone acetonide 0.01%, hydroquinone 4.0%, and tretinoin 0.05% (Tri-Luma), Balkrishnan and colleagues led a community-based trial at 393 centers in the United States. The Prospective Investigation Gauging Melasma Reduction with a New Treatment (PIGMENT) trial was an open-label phase IV study conducted on 1290 patients. Patients with melasma who were pregnant or nursing; could not avoid significant sun exposure; had recently taken any systemic medications that might confound results; had recently used any topicals, cosmetics, or procedures that could interfere with the cream; had sensitivities to any ingredients of the medication; had a history of alcohol or drug abuse; or had any skin conditions that could interfere with the trial were excluded. These criteria were used to ensure that only patients with chronic melasma were included. Ninety-six percent of patients were women, and, notably, 62.2% of patients were white, with only 15.8% of Hispanic origin, 10.1% African American, and 7.3% Asian. Patients applied the cream to lesions once nightly and were evaluated at 4 and 8 weeks by the MASI and an investigator’s global assessment of improvement. At baseline and at 8 weeks, 1076 patients completed a comprehensive patient health questionnaire, including a skin discoloration impact evaluation questionnaire containing a few items that were later validated and included as part of the MELASQOL described previously. With a baseline mean MASI of 14.68, the trial demonstrated significant improvement of lesions at 4 weeks (mean MASI, 7.38) and even greater improvement at 8 weeks (mean MASI, 3.64) as measured by the mean MASI score across all races and Fitzpatrick skin types. Moderate to marked improvement in the investigator’s global assessment was also reported. Responses to the QOL questionnaire showed improvement in areas pertaining to feeling self-conscious or scrutinized, feeling unattractive, using cosmetics to conceal lesions, and limiting social or leisure activities because of melasma, although a statistical quantification of this improvement was not presented. The trial also demonstrated that more than 50% of patients experienced significant improvement in QOL, as they felt less embarrassed, used fewer cosmetics, made fewer efforts to hide their skin, felt younger, and felt more attractive after treatment. Although the MELASQOL was not used in the PIGMENT trial, it was a large multicenter study that made an important step toward understanding melasma by following up patients undergoing treatment over time and characterizing the effects of melasma on QOL. Further studies should use the validated MELASQOL to evaluate its responsiveness, following patients for long-term effects, comparing multiple groups with different treatments, and sampling an even more diverse cross section of the population affected by melasma.
Melasma in Latino men
Pichardo and colleagues pooled data from 3 population studies of the prevalence of melasma in Latino men, which were collected by the Wake Forest University School of Medicine. The first study consisted of 25 male Latino poultry workers in North Carolina, the second cross-sectional study consisted of 55 male Latino farm workers in North Carolina, and the third longitudinal study comprised 300 male Latino farm workers. All patients completed a Mexican Spanish version of the DLQI to assess QOL, and demographic information such as age, nationality, and language spoken was collected. Diagnosis of melasma was made by direct examination by a dermatologist in the first 2 studies and by photographs evaluated by a dermatologist in the third study. Half of the participants were 30 years or younger. Ninety-two percent of the poultry workers were Guatemalan, and 96.3% and 98.7% of the cross-sectional and longitudinal farm workers, respectively, were Mexican. Ninety-two percent of the poultry workers spoke an indigenous language, whereas 87.3% of the longitudinal farm workers spoke only Spanish. Across all 3 studies, the prevalence of melasma was 14.5%. The melasma prevalence in the poultry worker study alone was 36%, and all these patients with melasma spoke an indigenous language. Patients older than 31 years had the highest prevalence of melasma at 70%, whereas melasma was not present in any of the workers aged 18 to 24 years. In the cross-sectional farm worker study, melasma was present in 7.4% of the participants, and all were of Mexican nationality. The prevalence was higher in those older than 31 years, but the condition was also present in those aged 18 to 24 years. In the longitudinal farm worker study, the prevalence of melasma was 14%, with all age groups affected, although, once again, the oldest age group (>31 years) had the highest prevalence. In this study, 50% of the men with melasma were Guatemalan, whereas 13.5% were Mexican. In addition, participants who spoke an indigenous language had a higher prevalence than those who spoke only Spanish (21.1% vs 13%).
In the poultry worker study, there was a statistically significant difference in the total DLQI between men with and without melasma. Men with melasma had a higher mean DLQI score of 7.5 than men without melasma at 2.8, indicating poorer QOL due to melasma. Latinos often associate melasma with ill health and poor nutrition. However, this correlation between melasma and QOL in Latino men could be confounded by other unknown shared demographic characteristics. Furthermore, the Mexican Spanish version of the DLQI may not have been appropriate for the primarily indigenous language–speaking participants in the first study. Further studies of the effect of melasma on QOL in Latino men should collect more demographic information, such as comorbidities and family history of melasma, to allow for improved comparison with other studies and to better characterize this minority group.
Spanish MELASQOL
To address the increasing Latino population in the United States and its high prevalence of melasma, Dominguez and colleagues adapted the MELASQOL to the Spanish language for use in multiple Spanish-speaking populations (see Box 2 ). The final Spanish-language MELASQOL (Sp-MELASQOL) was administered to 111 female patients with melasma recruited from a county hospital outpatient primary care clinic in Texas. Inclusion criteria consisted of female sex, melasma, at least 18 years of age, Hispanic origin, and the ability to read and understand Spanish. Exclusion criteria included pregnancy in the last 6 months, menopause, and history of bilateral oophorectomy to study patients with chronic melasma rather than those with transient melasma associated with pregnancy and those who might be on hormone replacement therapy. In addition to the Sp-MELASQOL and health-related QOL validation questionnaire used in the original MELASQOL, investigators collected demographics and medical and psychiatric histories and determined patient MASI scores.
Related posts:
Health-Related Quality of Life in Dermatology: Introduction and Overview
Overview of Health Status Quality-of-Life Measures
Quality-of-Life Issues in Vitiligo
Quality-of-Life Instruments: Evaluation of the Impact of Psoriasis on Patients
Clinical Meaning in Skin-specific Quality of Life Instruments: A Comparison of the Dermatology Life Quality Index and Skindex Banding Systems
Future Directions in Dermatology Quality of Life Measures
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