Introduction

Cutaneous leishmaniasis (CL) is a neglected parasitic disease endemic to tropical and subtropical regions, affecting millions of people worldwide. This illness is characterized by debilitating cutaneous and mucosal lesions, which can substantially impair patients’ quality of life [1,2], influencing physical [3], psychological [4], social, and economic dimensions [5,6]. Assessing health-related quality of life (HRQoL) is essential to fully understand the impact of CL, ensure that patient’s well-being is considered, and guide both therapeutic interventions and public health policies.

Advances in medical treatments have expanded the range of therapeutic options available for diseases with long-term symptoms, such as CL, leading to increased interest in evaluating and comparing these interventions. In this context, assessing HRQoL is essential not only to evaluate the clinical effectiveness of treatments but also to capture their impact on patients’ daily lives and overall well-being. Although studies on HRQoL provide valuable information on how diseases and treatments affect individuals’ overall well-being, as far as we are concerned, the scientific literature on CL is still largely limited to cross-sectional studies [2,7–12]. These studies provide only one a static view of CL’s effects on individuals, failing to capture changes over time. In this context, the dynamic nature of longitudinal studies allows for observing the evolution of health conditions and the impact of interventions on HRQoL, offering a more comprehensive and detailed understanding of quality of life. Identifying the areas most affected by the disease can facilitate the design of patient-centered treatments and management strategies, promoting interventions that address specific needs and improve the overall care experience [13].

Several tools have been proposed to assess HRQoL, from generic instruments such as the SF-36 (Medical Outcomes Study 36-Item Form Health Survey) [14] and the EQ-5D [15], developed by the EuroQol Group, to disease-specific tools such as the Cutaneous Leishmaniasis Impact Questionnaire (CLIQ) [16], designed to measure the impact of CL. However, the use of CLIQ still has limited trial experience regarding its potential to adapt to the characteristics of the disease, and further studies are needed to validate the tool’s responsiveness [17].

In light of this, the present study aims to address this gap by comparing patients’ HRQoL at three time points: prior to the disease onset, at diagnosis, during treatment (up to 30 days post-treatment), and after treatment completion, utilizing the CLIQ as the assessment tool. Furthermore, understanding the temporal dynamics of HRQoL in CL patients can guide the development of patient-centered care pathways and support the integration of psychosocial interventions into routine clinical management. These findings have potential implications for other endemic regions facing similar challenges, including limited access to care, social stigma, and treatment-related burdens, particularly in low- and middle-income countries where CL remains underprioritized in public health agendas.

Methods

Results

Participants’ characteristics

A total of 143 patients diagnosed with CL, MCL, or ML were recruited, of whom 120 completed the longitudinal assessments, representing to a 16% loss to follow-up. Although the inclusion criteria permitted enrollment of individuals aged 12 years and older, no participants aged 12–14 years were enrolled during the study period; therefore, the youngest age included in the analysis was 15 years. At the baseline, the mean age of participants was 52 years (median 53; IQR 41–64), 73.4% were male (105/143), and 52.4% presented with a single lesion. The lower limbs were the most affected body region, accounting for 365 lesions (59.2%), followed by the mucous membranes of the nose and mouth, which comprised 112 lesions (18.1%). The distribution of clinical phenotypes was as follows: 74.1% CL (106/143), 11.1% ML (16/143), and 7.6% MCL (11/143). Baseline sociodemographic and clinical characteristics of participants who completed follow-up (n = 120) are presented in Table 1.

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Table 1. Sociodemographic and disease characteristics of participants (n = 120).

https://doi.org/10.1371/journal.pone.0334215.t001

Participants’ CLIQ scores

The overall median CLIQ scores at the three assessed time points were as follows: 1. prior to treatment, 24 (Q1: 16–Q3: 36); 2. during treatment, 23 (Q1: 16–Q3: 35.5); and 3. post-treatment, 15 (Q1: 8.25–Q3: 25). A significant positive linear correlation was observed across the scores at all time points, indicating consistency in the responses (time point 1 vs. time point 2, r = 0.762; time point 1 vs. time point 3, r = 0.498; time point 2 vs. time point 3, r = 0.635; p < 0.001). As shown in Fig 1, scores differed significantly between the pre-treatment and post-treatment time points (p < 0.001), indicating a greater disease impact at baseline. A significant difference was also observed between scores recorded during treatment and those obtained after treatment completion (p < 0.001). In contrast, no significant difference was found between scores obtained before the start of treatment and those recorded during therapy.

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Fig 1. Comparison of CLIQ overall scores over the follow-up period in patients with cutaneous leishmaniasis.

Time points: 1. prior to treatment; 2. during treatment; and 3. post-treatment. *p < 0.05.

https://doi.org/10.1371/journal.pone.0334215.g001

CLIQ domains

Domain scores were calculated by summing the individual items comprising each respective CLIQ domain. A significant improvement in patients’ perception of the overall impact of CL was observed when comparing the pre-treatment and the post-treatment periods (p < 0.001), as well as between the treatment and post-treatment periods (p < 0.001). No significant difference was found between the pre-treatment and during-treatment time points (p = 0.058). In the domain evaluating patients’ perceptions of treatment and access to health services, scores were significantly higher during treatment compared to the post-treatment period (p = 0.010). However, no significant differences were observed between the pre-treatment and during-treatment periods, nor between the pre-treatment and post-treatment periods for this domain. These findings are illustrated in Fig 2.

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Fig 2. Percentage of domain scores (A) General Impact (B) Perception about health services and treatment, and median/interquartile range (IQR) of CLIQ across follow-up periods.

Time points: 1. prior to treatment; 2. during treatment; and 3. post-treatment. *p < 0.05.

https://doi.org/10.1371/journal.pone.0334215.g002

CLIQ items

Table 2 presents the frequency of responses categorized as “some problems” among individuals reporting difficulties related to CL within the general health impact domain of the CLIQ, assessed before, during, and after treatment. Descriptive analysis revealed a decrease in perceived overall health impact (item 1), declining from 85.0% before treatment to 44.1% post-treatment. Difficulties related to physical activity (item 2) decreased from 51.6% to 20.8%, and challenges in work or study capacity (item 3) dropped from 50% to 22.5%. Reports of local symptoms (item 9) and concerns about skin lesions (item 10) also diminished over the course of treatment. However, certain issues persisted to some extent, including the need to miss work (item 13), the requirement to pay for a substitute (item 15), perceived financial burden (item 5), and feelings of social isolation (item 6).

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Table 2. Frequency of ‘Some Problems’ responses in CLIQ Questionnaire’s General Health Impact domain across three evaluation points: Before, During, and After Treatment (n = 120).

https://doi.org/10.1371/journal.pone.0334215.t002

Regarding the perception of the medication used (item 19), 52.5% of participants rated it as “Very good” during treatment, increasing to 66.7% after treatment, representing an absolute increase of 14.2%. In contrast, item 22, which assesses the frequency of feeling unwell due to the medication, showed a 5.8% increase in the response “Sometimes” and a slight decrease of 1.7% in “Frequently”. It is important to highlight that items 19 and 22 were not assessed at baseline, limiting direct comparisons with the initial condition. Additionally, reliance on health services for change wound dressing (item 23) decreased, with a 28.3% increase in the response “Never” post-treatment. Frequencies for all items related to treatment perception and health service use are presented in Table 3.

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Table 3. Frequency of responses of patients’ perceptions of treatment and health services domain in CLIQ Questionnaire, across three evaluation points: Before, During, and After Treatment (n = 120).

https://doi.org/10.1371/journal.pone.0334215.t003

Discussion

The results of the overall CLIQ scores indicate a significant positive impact of the various treatments on the patients’ perceived quality of life, when comparing pre-treatment and post-treatment scores. As anticipated, no significant differences were found between scores obtained before and during treatment, as symptom resolution of CL is typically perceived only after 90–180 days following treatment initiation [18].

The present findings suggest that although several areas of difficulty improved following treatment, economic and emotional challenges persisted, underscoring the need for additional support to address the financial and emotional dimensions of CL [6]. Analysis of items related to the impact of treatment and health services revealed increased variability in responses during and after treatment. This indicates that while some patients reported improvements and held positive perceptions of their care, others continued to experience difficulties or perceived the treatment process and health services negatively. This variability in responses suggests that patients’ experiences with treatment were more heterogeneous, reflecting a broad spectrum of individual perceptions and outcomes. While treatment was effective for some, others faced distinct or additional challenges during the recovery process [19].

Although treatment resulted in noticeable improvements in patients’ HRQoL and self-sufficiency, two key issues remained largely unchanged: financial burden and the feeling of social isolation. Despite a reduction in physical symptoms and increased independence, some patients continued to experience economic hardship due to treatment-related costs and loss of income, as well as feelings of social isolation, possibly linked to disease-related stigma or the inability to fully engage in social life. Although several studies have thoroughly examined the psychological impact of CL [1,4,20], the financial burden associated with the disease remains underexplored in the existing literature. Available evidence indicates that CL treatment can be economically burdensome, particularly in settings with limited access to quality health services and where travel and medication costs are substantial [5,21]. Recent evidence has further emphasized the substantial economic burden associated with CL treatment, underscoring significant out-of-pocket expenses and indirect costs related to productivity loss and transportation—factors that disproportionally affect vulnerable socioeconomic groups [6]. Accordingly, our findings highlight the need for complementary interventions, including financial assistance, psychological support programs, and patient and family support groups, to address the financial and emotional dimensions of CL that are often underestimated in clinical management, yet have a substantial impact on patients’ quality of life.

This study found that perceived dissatisfaction with treatment and access to health services was greater during the treatment phase, suggesting that the challenges encountered at this stage may contribute to heightened emotional distress. These findings are consistent with previous research reporting elevated dissatisfaction among patients undergoing treatment, particularly in relation to access barriers and logistical difficulties [7]. Additionally, variations in responses between the treatment and post-treatment periods reflect a broader spectrum of experiences and perceptions, likely influenced by individual differences in emotional resilience and the availability of social support. These perceptions may also be shaped by factors such as injury severity, treatment response, and the extent of economic support received. This echoes conclusions drawn in a qualitative study of Tunisian CL patients, who reported significant physical and emotional burden during treatment, along with frustration regarding limited efficacy and poor healthcare access, underscoring the importance of patient-centered care and the integration of psychosocial support into CL case management [19]. Although the present study was not designed to establish causal relationships, our findings offer valuable insights that can inform future research and clinical practice, contributing to a more comprehensive understanding of the challenges faced by patients.

Analysis of response frequencies for each questionnaire item revealed that the proportion of patients rating the medication as “very good” increased following completion of treatment, while ratings of “good,” “fair,” and “poor” decreased. However, a slight increase was observed in the number of patients who rated the treatment as “very poor”. These evaluations may reflect a heightened perception of cure at the end of treatment. Furthermore, the use of parenteral medications may have contributed to less favorable assessments during the treatment period; however, with the achievement of cure, any transient discomfort may be disregarded. Additionally, an increase in the frequency of reported adverse events was observed throughout the treatment. These findings highlight the importance of continuous monitoring and adjustments during treatment to enhance patient satisfaction and manage adverse events effectively [22].

Hospitalization was not assessed as a study variable in this research. At the reference center, only patients treated with amphotericin B required inpatient care for drug administration, while all other treatments were delivered on an outpatient basis. Notably, only 7.5% of participants received amphotericin B. Although inpatient care was outside the scope of our analyses, future studies should consider evaluating hospitalization status and duration, as the need for inpatient treatment may impact patients’ quality of life, treatment burden, adherence, and overall costs. Previous studies in CL have highlighted that economic costs, treatment logistics, and access to health services are important determinants of HRQoL [6,21], reinforcing the potential value of incorporating hospitalization into patient-reported outcome assessments.

The main limitations of this study include the lack of a representative sample of the broader population affected by CL, stemming from its single-center design and reliance on convenience sampling. Additionally, conducting interviews at the same health center where patients receive care may have introduced response bias—specifically, “gratitude bias”—whereby patients may have overstated improvements in their quality of life due to please the interviewer or to appear cooperative.

The longitudinal design may also have introduced biases due to loss to follow-up over time, complicating consistency in data collection. Moreover, the analytical approach adopted for item evaluation was predominantly descriptive and lacked methodological rigor, which may have limited the identification of definitive associations. Furthermore, the lack of control over external variables (such as variations in the treatment environment, adherence levels, social support, and comorbidities, among others), combined with the use of a non-representative sample, may have constrained the generalizability of the results.

Another limitation lies in the consolidation of intensity and frequency response categories in the CLIQ into a single category labeled “some problems”. This simplification may hinder a comprehensive overview of patient improvements, potentially omit important information, and limit the detection of subtle yet clinically relevant changes. Furthermore, it fails to capture improvements that do not result in a shift to “no problems,” such as a reduction from severe to moderate issues. This approach also diminishes the sensitivity and specificity of the assessment compared to more detailed versions of quality-of-life measurement instruments, thereby compromising the analysis of gradual and multidimensional improvements in patient health.

Despite these limitations, the study contributes meaningfully to the understanding of patients’ lived experiences. While CL treatment significantly improves HRQoL in terms of physical symptoms and self-sufficiency, economic and emotional challenges persist as critical areas that requiring ongoing attention. The diversity in patient responses throughout the treatment process highlights the importance of personalized and integrated approaches that consider every dimension of patients’ lives, rather than focusing solely on the physical symptoms of the disease.

This study supports the need for integrated public health responses to CL that go extend clinical cure, incorporating financial support mechanisms, psychosocial care, and community-based education aimed at reducing stigma and improving adherence. Such strategies could be embedded within national neglected tropical disease control programs, particularly in endemic regions where social vulnerability, geographic barriers, and resource constraints intensify the burden of illness. Tailored policies that recognize HRQoL as a critical outcome can foster more equitable and effective care for populations affected by CL.

Acknowledgments

The authors would like to express their gratitude to Instituto René Rachou (Fiocruz Minas), Fundação Oswaldo Cruz, and Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM) for their invaluable support throughout the development of this research.