A Quality of Life Study in Patients with Leprosy Using DLQI and WHOQOL-BREF Questionnaires.

CONTEXT: India accounts for 60% of the global leprosy burden. Deformities lead to a negative impact on the quality of life (QoL). There is a paucity of Indian studies evaluating the QoL in patients with leprosy. AIMS: This study was undertaken to assess QoL in leprosy patients with two different questionnaires, correlate QoL with demographic and clinical profile and evaluate the impact on health-related QoL scores. SETTINGS AND
DESIGN: A cross-sectional study to evaluate the QoL was conducted in the dermatology OPD of a tertiary center in Maharashtra, India.
MATERIALS AND METHODS: Demographic and clinical profile along with evaluation of QoL using DLQI and WHOQOL-BREF questionnaires was conducted in 60 leprosy patients. STATISTICAL ANALYSIS USED: Parametric test, R test, Chi-square test, Z test, Student's t-test (t), and Pearson's correlation coefficient (r) were used.
RESULTS: The mean DLQI score was 8.4 ± 4.4 and 40% of patients had moderate impact on QoL, and the mean WHOQOL-BREF score was 3.13 ± 0.9. The demographic profile, type of leprosy and reactions did not have a statistically significant correlation with DLQI. Presence of deformity had significant impact on DLQI and a statistically significant impact on physical, psychological, and environmental domain in WHOQOL-BREF analysis.
CONCLUSIONS: Deformities have a profound impact on QoL in leprosy patients on evaluation with DLQI and WHOQOL- BREF questionnaires. The social domain was least affected, whereas severe impact was noted in psychological domain. DLQI is a practical and simple questionnaire, whereas WHOQOL- BREF provides a comprehensive approach on all domains. Copyright:

Introduction

Leprosy continues to be a public health problem in India irrespective of the availability of effective multi-drug therapy for more than three decades. The successful implementation of the National Leprosy Elimination Programme (NLEP) in India has helped to bring the prevalence rate of 57.8/10,000 in 1983 down to 0.66/10,000 in 2016. Despite this success, India continues to account for 60% of new cases reported each year globally.[1] The stigma associated with leprosy and deformities result in decreased social functioning, reduced self-esteem, and patient's isolation from society, even in cured patients, thereby impacting their QoL. The World Health Organization defines QoL as the “individual's perception of their position in the context of culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns.”[2] Very few Indian studies have assessed the QoL and examined the psychological and social impact. Hence, the primary objective of this study was to assess the QoL of patients in leprosy using Dermatology Life Quality Index (DLQI)[3] and WHOQOL-BREF[4] questionnaires and to find out the correlation of QoL with demographic and clinical profile of patients. The secondary objective was to evaluate the impact of various demographic and clinical factors on the health-related QoL scores in both questionnaires.

Materials and Methods

A hospital-based, single-observer cross-sectional study, conducted over 2 months, included 60 patients of leprosy attending the dermatology out-patient department of a tertiary centre in Maharashtra, India after Ethics Committee approval.

All patients, diagnosed with leprosy, above 18 years of age and willing to give an informed consent were included. The demographic data was recorded in the case record sheet, which included particulars such as age, gender, occupation, and mode of detection. The disease profile included type of leprosy, presence of reaction, and grade of deformity.

The impact on QoL was assessed using Dermatology Life Quality Index (DLQI) and WHOQOL-BREF questionnaires. English, Hindi, and Marathi versions of the questionnaires were validated and used with appropriate permissions. The DLQI questionnaire includes 10 questions, which analyze six domains namely symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The score of each question is summed up to a maximum of 30 and a minimum of 0 score. The higher the score, more is the QoL impairment.[3] The score is assessed as follows: 0-1 (no effect), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect), and 21-30 (extremely large effect). The WHOQOL-BREF questionnaire consists of 26 questions. Two questions evaluate subjective assessment of overall perception of QoL and satisfaction with health, and 24 questions assess the four domains namely, physical health (seven items), psychological health (six items), social relationships (three items), and environment (eight items). Each item uses a 5-point response scale. Higher scores indicate a higher QoL.

Data was entered into Microsoft Excel version 2013 and analyzed using parametric test, R test, Chi-square test and Z test. The Student's t-test (t) was used to detect mean difference between two groups. Pearson's correlation coefficient (r) was used to test for the correlation between QoL scores. A P value of less than 0.05 was considered statistically significant.

Results

The demographic and clinical profile of the patients is shown in Table 1.

Table 1

Demographic and clinical profile of patients (n=60)

Demographic and clinical data	Number of patients (%)
Gender
Male	32 (53.3%)
Female	28 (46.7%)
Age (in years)
18-30	19 (31.7%)
30-60	26 (43.3%)
>60	15 (25%)
Employment
Nonworker	27 (45%)
Semiskilled	7 (11.7%)
Unskilled	26 (43.3%)
Mode of Detection
Voluntary reporting	34 (56.7%)
Healthcare workers	8 (13.3%)
Consultation for other ailments	18 (30%)
Type of leprosy
Multibacillary	52 (86.7%)
Paucibacillary	8 (13.3%)
Presence of reaction
No reaction	30 (50%)
Type 1	16 (26.7%)
Type 2	14 (23.3%)
Grade of deformity
0	13 (21.7%)
1	11 (18.3%)
2	36 (60%)

DLQI score of all patients was calculated and the correlation was performed with respect to demographic and disease factors [Table 2]. The mean DLQI score was 8.4 ± 4.4 with a range of 0-21. Among a total of 60 patients, leprosy had no impact on QoL in two patients (3.3%). The scores showing small, moderate, large, and severe effect was observed in 14 (23.3%), 24 (40%), 19 (31.6%), and one (1.6%) patient, respectively. Higher DLQI score was seen in the female population and among older age group. However, demographic profiles of age, gender, and occupation did not have a statistically significant correlation with DLQI. Majority of patients had multibacillary (MB) type of leprosy (86.7%, n = 52) and eight patients (13.3%) had paucibacillary (PB) type. Though QoL was affected in all patients (except in one case each of MB/PB), the type of leprosy did not have a statistically significant correlation with the DLQI (Chi-square = 2.31, df 1, P > 0.05, difference is not significant). Thirty patients (50%) had presence of reaction during their course of illness. Among 30 patients, type 1 reaction was present in 16 (26.7%) and type 2 reaction was present in 14 (23.3%) patients. All patients with either type of reactions had an impact on their QoL. No statistically significant correlation was found between the presence of reaction and DLQI scores. (Chi-square = 1.37, df 2, P > 0.1, difference is not significant). Deformity was present in 47 (78.3%) patients. Presence of deformity showed a higher DLQI score and had a negative impact on QoL. Among 36 patients with grade 2 deformity, small, moderate, and large effects on QoL was seen in eight (13.33%), 13 (21.66%), and 15 (25%) patients, respectively. In 11 patients with grade 1 deformity, small, moderate, and large effects on QoL was seen in one (1.66%), five (8.33%) and five (8.33%) patients, respectively. Presence of deformity had a statistically significant correlation with DLQI scores (Chi-square = 6.55, df 2, P < 0.05) The scatter diagram showing a positive correlation between DLQI and grades of deformity is shown in Figure 1.

Table 2

Correlation of DLQI score with respect to demographic and clinical profile

Demographic and clinical data	No of patients (n)	DLQI Scores and Number of patients (n)
		No effect (0-1) n=2	Small effect (2-5) n=18	Moderate effect (6-10) n=24	Very large effect (11-20) n=19	Extremely large effect (21-30) n=1
Gender
Male	32	2	6	15	8	1
Female	28	0	8	9	11	0
P>0.1
Age
<30	19	0	5	9	4	1
30-60	26	2	9	12	7	0
>60	15	0	4	3	8	0
P=0.12
Type of Leprosy
MB leprosy	52	1	11	23	17	0
PB leprosy	8	1	3	1	2	1
P>0.05
Presence of Reaction
No reaction	30	2	8	11	8	1
Type 1	16	0	3	6	7	0
Type 2	14	0	3	7	4	0
P>0.1
Grade of Deformity
0	13	2	5	4	1	1
1	11	0	1	5	5	0
2	36	0	8	15	13	0
P<0.05*

MB: Multibacillary, PB: Paucibacillary, *P<0.05 (statistically significant)

Figure 1

Scatter diagram showing a positive correlation between grades of deformity and DLQI

The mean WHOQOL-BREF score for overall QoL was 3.13 ± 0.9. The correlation of various domains in WHOQOL-BREF with respect to demographic and clinical profile is shown in Table 3. The mean score in physical health domain was 51.08 ± 21.10, psychological health domain was 35.70 ± 22.04, social relationship domain was 55.30 ± 22.70, and environmental domain was 49.13 ± 16.40. On analysis of different domains, worst impact was observed in the psychological domain followed by environmental and physical domain. The social relationship domain was the least affected. Figure 2 depicts the QoL in different domains. The mean QoL scores for females were lower than males in all four domains. However, no statistically significant difference was observed between genders in all four domains of QoL. On comparing age in relation to QoL, statistically significant difference was observed only in physical health domain with a better QoL in the 30–60-year age group followed by the younger patients (18–30 years). The older age group (>60 years) had the most severe impact on QoL. No significant difference was observed with the type of leprosy in all four domains. The presence of reaction had a significant difference in the social domain. The presence of deformity had a significant effect on physical, psychological, and environmental domains, whereas social domain remained unaffected.

Table 3

Correlation of various domains in WHOQOL- BREF with respect to demographic and clinical profile

Demographic and clinical data	No of patients (n)	Physical health Mean±SD	Psychological health Mean±SD	Social relationship Mean±SD	Environmental health Mean±SD
Gender
Male	32	57.3±24	38.8±20.9	57.1±20.7	51.5±15.5
Female	28	43.9±14.6	32.2±23.1	53.2±25	46.4±17.3
P		0.26	0.27	0.28	0.21
Age (years)
<30	19	43.9±14.6	32.2±23.1	53.2±25	46.4±17.3
30-60	26	57.3±24	38.8±20.9	57.1±20.7	51.5±15.5
>60	15	36.5±16.5	36.8±25	47.9±20	45.4±17.8
P		0.00*	0.94	0.21	0.57
Type of leprosy
MB leprosy	52	50.02±20.58	35.4±22.3	54.5±23.6	49±16.6
PB leprosy	8	58±24.5	37.6±21.7	60.9±15.8	50.3±15.7
P	0.22	0.23	0.25	0.29
Presence of Reaction
No reaction	30	56.33±19	39.67±15.91	61.6±20.69	52.47±15 65
Type 1	16	45.5±22.45	29.38±22.48	44.94±23.01	44.19±16.45
Type 2	14	46.21±22.48	34.43±31.15	53.64±23.37	47.64±17.43
P		0.16	0.32	0.05*	0.25
Grade of deformity
Grade 0	13	68.38±23.19	42.46±16.73	62.77±27.66	59.23±12.09
Grade 1	11	47.27±13.07	20.45±13.16	54.55±23.75	43.91±13.6
Grade 2	36	46±19.36	37.92±24.05	52.83±20.44	47.08±17.31
P		0.00*	0.03*	0.4	0.03*

SD: Standard deviation, MB: Multibacillary, PB: Paucibacillary. *P<0.05 (statistically significant)

Figure 2

Quality of Life in different domains (WHOQOL- BREF)

Discussion

Leprosy, one of the most ostracized diseases, has been described as early as 600 BC. WHO launched a 5-year “Global leprosy strategy 2016-2020” in April 2016 titled 'Accelerating towards a leprosy free world'[5] The strategy aimed to eliminate leprosy by effective treatment, effective methods of contact tracing, and monitoring drug resistance. It also aimed on focusing on the important challenge of persistent discrimination against people affected by leprosy. The physical disabilities caused by leprosy are a major cause of social stigma leading to social isolation of the affected individuals. As the impairments are permanent, these deformities have a huge negative impact on the QoL even after the disease is cured. Though India houses a major part of the global leprosy burden, the effect on QoL remains relatively unexplored. There is a paucity of studies to find out the impact of demographic and disease-related factors on the QoL of leprosy patients. This study used two different QoL indices, DLQI and WHOQOL-BREF.

The mean DLQI score was 8.4 ± 4.4 with a range of 0-21 and most patients (n = 24, 40%) had a moderate impact on their QoL; this was similar to a study conducted in eastern India, which reported a mean DLQI of 8.48.[6] In contrast, studies conducted in Brazil and Egypt reported a mean DLQI of 10.23 and 11. 58, respectively, indicating a large effect on the QoL.[78] A mean score of 18.78 was reported in patients with lepromatous leprosy in China.[9] A study conducted in Vietnam also reported high DLQI scores in both treated and cured cases of leprosy.[10] Thus, a moderate impact on QoL has been reported in Indian studies as compared to the larger effect on QoL in other countries.

Leprosy was more frequent in males than females in this study and these findings have been corroborated in other Indian studies.[611] This could be attributed to higher rate of outdoor activity in males, thereby increasing their chances to acquire the infection or probably due to their increased access to the healthcare system. The QoL was impaired more in females as compared to males, however it was not statistically significant. Das et al.[6] and Bello et al.[12] have found that females have poorer QoL than males and gender was a major determinant of QoL. Higher DLQI score seen in the older age group corroborates with the findings reported by Das et al.[6] and Bello et al.;[12] however, age was not a strong factor for determining QoL. Majority of the patients in this study were MB type (86.7%) and had a higher mean DLQI. This could be because patients with MB leprosy have higher incidences of reactions and neurologic complications leading to increased disability, thereby worsening the QoL. Similar findings have been reported in Brazilian studies.[713] In a study of PB cases, 63% of patients reported no compromise in QoL.[14] A study conducted by Lustosa et al.[15] in Brazil showed that reactional states are a major determinant affecting the QoL. Similar findings were reported in Malaysia wherein poor QoL was seen in the presence of reactions.[16] Lepra reactions are associated with systemic symptoms leading to pain, discomfort, and increased pill burden. This could lead to increased leave at work and financial constraints. However, the result of the study was discordant with these studies and there was no significant correlation between the presence of reaction and DLQI. Presence of deformity had a statistically significant correlation with the DLQI scores corroborating the findings of Das et al.[6] The deformities in leprosy patients worsen their self-esteem and interferes with various aspects of life such as appearance, interpersonal relationship, and work. The attitude of discrimination and rejection towards leprosy patients is always more in the presence of physical deformities leading to deprivement of employment opportunities and worsening their QoL. Similar findings were observed in the Malaysian study, which showed that patients with physical deformities had a higher impact on the QoL.[16] However, a study conducted in Brazil found that deformities do not affect the QoL.[17]

The mean WHOQOL-BREF score for overall QoL was 3.13 ± 0.9; this was similar to the findings of an Egyptian study.[8] Analysis of WHOQOL-BREF scores showed that the mean score was the lowest in the psychological health domain in this study, thereby indicating a severe impact on the mental well-being of patients. The social domain was least affected. Mankar et al.[18] reported lower scores in physical and psychological domains, and environmental and social domains being the least affected. Though leprosy is considered to be a social stigma in India, the social domain was the least affected in this study. Mohta et al.[19] evaluated the role of endocrinological dysfunction in lepromatous leprosy and found that most patients scored the lowest on the social domain followed by psychological health. In an Egyptian study, the social, psychological, and physical domains were the most affected compared to the environmental domain.[8]

The study results showed overall lower scores in all four domains for females compared to males and corroborated with other studies.[202122] On the contrary, Mankar et al.[18] found that psychological and environmental domains were significantly affected in females indicating greater discrimination against females as compared to males by the society. With respect to age factor, a statistically significant difference was seen only in the physical domain among various age groups in this study, with the older age group showing a severe impact on the QoL. This may be attributed to increased dependency on the family members for personal care and added disease burden with other coexisting co-morbidities. This was concordant with the findings of Dinesh et al.[21] and Govindharaj et al.[22] The type of leprosy (MB or PB) did not have statistically significant difference on QoL in any of the domains and corroborated with the findings observed by Costa et al.[20] However, Lustosa et al.[15] reported that MB leprosy was crucial in worsening the QoL due to functional limitations, social aspects, and increasing the risk of disabilities. The presence of reaction had a significant difference on the QoL only in the social domain in this study. Santos et al.[23] reported a poor QoL in the presence of reaction due to functional activity limitations especially in physical and environmental domains. Impaired QoL in all the domains in patients with deformities has been reported in various studies.[202224] However, in this study, a statistically significant difference was seen in all domains except social domain.

DLQI is a dermatology-specific health-related QoL questionnaire and WHOQOL-BREF is a 26-item version of WHOQOL-100. It has been postulated that WHOQOL-BREF has an advantage over DLQI due to its varied questions and multiple domains.[8] In this study, we noted that the presence of deformities had a statistically significant correlation in both DLQI and WHOQOL-BREF questionnaires. Other demographic and clinical factors had no statistical significance in DLQI, whereas WHOQOL- BREF showed a statistical significance with respect to age in physical domain and presence of reaction in social domain. DLQI questionnaire is simple, easy to administer, practical, and can be used in routine clinical practice. WHOQOL- BREF provides a comprehensive approach on overall QoL and health status of the individual and addresses the physical, psychological, social, and environmental domains. It can be a useful tool in research settings and evaluate interventional approaches in leprosy-control programs. The limitation of this study was the small sample size due to short-study duration period.

Conclusions

QoL in leprosy was impaired significantly by the presence of deformities in both DLQI and WHOQOL-BREF scores. Females and older age group individuals had a lower QoL. The social domain was least affected and severe impact on psychological domain was noted. Early detection and timely treatment are important in the prevention of deformities, which will thereby reduce the negative impact on QoL. Hence, a holistic approach, which not only addresses the pharmacological measures but also the psychological aspects and prevention of disabilities, is needed. DLQI is a practical and simple questionnaire, whereas WHOQOL- BREF provides a comprehensive approach on all domains. Use of these indices should be encouraged in clinical practices and research settings.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.