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Research Article | Volume 14 Issue: 4 (Jul-Aug, 2024) | Pages 126 - 132
Observational Analysis of Treatment Adherence and outcomes in patients with Vitiligo
 ,
 ,
 ,
1
Associate Professor, Department of Dermatology, Venerelogy and Leprosy, Mamata Academy of Medical Sciences, Hyderabad, Telangana, India
2
Assistant Professor, Department of Dermatology, Venerelogy and Leprosy, Mamata Academy of Medical Sciences, Hyderabad, Telangana, India
Under a Creative Commons license
Open Access
DOI : 10.5083/ejcm
Received
May 15, 2024
Revised
June 5, 2024
Accepted
June 25, 2024
Published
July 7, 2024
Abstract

Background:   Vitiligo is a chronic skin condition characterized by loss of pigmentation. Treatment adherence is crucial for achieving optimal clinical outcomes. This study investigates the relationship between treatment adherence and clinical outcomes in patients with vitiligo. Methods: A total of 100 patients with vitiligo were observed over a 12-month period. Treatment adherence was categorized into high (≥80%), moderate (50-79%), and low (<50%) adherence groups. Clinical outcomes were assessed based on the percentage of repigmentation achieved and categorized into excellent (≥75%), good (50-74%), and poor (<50%) outcomes. Statistical analysis was conducted using chi-square tests to determine the association between adherence and outcomes. Results: The study included 60 females and 40 males, with a mean age of 35 years. The mean duration of vitiligo was 5 years. High adherence was observed in 40% of patients, moderate adherence in 35%, and low adherence in 25%. Clinical outcomes showed that 30% of patients achieved excellent repigmentation, 45% achieved good repigmentation, and 25% had poor outcomes. A significant association was found between adherence and outcomes (χ² = 38.2, p < 0.001). Adverse events were reported in 15% of patients, primarily mild skin irritation. The mean patient satisfaction score was 4.1, with 70% of patients reporting satisfaction with their treatment. Conclusion: Higher treatment adherence is significantly associated with better clinical outcomes in patients with vitiligo. These findings underscore the importance of adherence to prescribed treatments for achieving optimal repigmentation and patient satisfaction.

Keywords
INTRODUCTION

Vitiligo is a chronic skin disorder characterized by the progressive loss of melanocytes, resulting in depigmented patches on the skin1. Affecting approximately 0.5% to 2% of the global population, vitiligo can have significant psychosocial impacts due to its visible nature and association with stigmatization2. The etiology of vitiligo is multifactorial, involving genetic, autoimmune, and environmental components3. Despite extensive research, the pathogenesis of vitiligo remains incompletely understood, complicating the development of universally effective treatments4.

Management of vitiligo typically involves a combination of therapies aimed at halting the progression of depigmentation and promoting repigmentation5. These therapies include topical and systemic corticosteroids, calcineurin inhibitors, Immunosuppressants, phototherapy, and, in some cases, surgical interventions. The effectiveness of these treatments varies widely among patients, necessitating a personalized approach to management6.

One of the critical factors influencing the success of vitiligo treatments is patient adherence. Adherence to prescribed treatment regimens is essential for achieving optimal clinical outcomes, yet non-adherence is common in chronic conditions. Non-adherence can result from various factors, including the complexity of the treatment regimen, side effects, lack of perceived efficacy, and psychological barriers7.

 

This study aims to investigate the relationship between treatment adherence and clinical outcomes in patients with vitiligo. By examining a sample of 100 patients over a 12-month period, this study seeks to quantify adherence levels, assess clinical outcomes in terms of repigmentation, and determine the statistical significance of the association between adherence and outcomes. Additionally, the study will evaluate adverse events and patient satisfaction to provide a comprehensive understanding of treatment dynamics in vitiligo management.

MATERIAL AND METHODS

This observational study was conducted at Mamata Academy of Medical Sciences, Hyderabad, from January 2023 to December 2023. The study aimed to investigate the relationship between treatment adherence and clinical outcomes in patients with vitiligo.

 

A total of 100 patients diagnosed with vitiligo were enrolled in the study. Inclusion criteria were patients aged 18-60 years with a confirmed diagnosis of vitiligo, who had been prescribed a treatment regimen for at least 12 months. Exclusion criteria included patients with other skin disorders or comorbid conditions that could interfere with the treatment of vitiligo.

 

Data were collected using structured interviews and medical record reviews. Baseline characteristics such as age, gender, duration of vitiligo, and treatment regimen were recorded.

 

Treatment adherence was assessed using patient self-reports and prescription refill records. Adherence was categorized into three levels:

  • High adherence: ≥80% of prescribed treatments completed
  • Moderate adherence: 50-79% of prescribed treatments completed
  • Low adherence: <50% of prescribed treatments completed

Clinical outcomes were evaluated based on the percentage of repigmentation achieved after 12 months of treatment. Outcomes were categorized as follows:

  • Excellent: ≥75% repigmentation
  • Good: 50-74% repigmentation
  • Poor: <50% repigmentation

Adverse events were monitored and recorded throughout the study period. Patient satisfaction was assessed at the end of the study using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).

 

Statistical analysis was conducted using SPSS software. Descriptive statistics were used to summarize baseline characteristics, adherence levels, clinical outcomes, adverse events, and patient satisfaction. The chi-square test was employed to assess the association between treatment adherence and clinical outcomes. A p-value of <0.05 was considered statistically significant.

 

The study was approved by the Institutional Ethics Committee. Written informed consent was obtained from all participants before enrollment. The confidentiality and privacy of all participants were strictly maintained throughout the study.

RESULTS

males, with a mean age of 35 years (range: 18-60 years). The average duration of vitiligo among the patients was 5 years, with a range of 1 to 20 years (Table 1).

 

 

Table 1: Demographic Characteristics

Characteristic

Value

Total patients

100

Female patients

60

Male patients

40

Mean age (years)

35

Age range (years)

18-60

Mean duration of vitiligo (years)

5

Duration range (years)

1-20

 

 

 

Figure No:1 Gender Distribution of Patients

 

Table 2: Treatment Adherence

Adherence Level

Number of Patients

Percentage (%)

High (≥80%)

40

40%

Moderate (50-79%)

35

35%

Low (<50%)

25

25%

 

 

Figure No:2 Treatment Adherence Levels among Patients

 

Treatment Adherence

Treatment adherence among the patients was categorized into three groups: high adherence (≥80% of prescribed treatments), moderate adherence (50-79% of prescribed treatments), and low adherence (<50% of prescribed treatments). The distribution was 40% in the high adherence group, 35% in the moderate adherence group, and 25% in the low adherence group (Table 2).

Table 3: Clinical Outcomes

Outcome Category

Number of Patients

Percentage (%)

Excellent (≥75%)

30

30%

Good (50-74%)

45

45%

Poor (<50%)

25

25%

 

Figure No:3.Clinical Outcomes of Patients

 

Clinical Outcomes

Clinical outcomes were assessed based on the percentage of repigmentation achieved after 12 months of treatment. Outcomes were categorized into three groups: excellent (≥75% repigmentation), good (50-74% repigmentation), and poor (<50% repigmentation). The results showed that 30% of patients achieved excellent outcomes, 45% achieved good outcomes, and 25% had poor outcomes (Table 3).

Association between Adherence and Outcomes

A strong association was observed between treatment adherence and clinical outcomes. Among patients with high adherence, 62.5% achieved excellent outcomes, 30% achieved good outcomes, and 7.5% had poor outcomes. In the moderate adherence group, 14.3% achieved excellent outcomes, 57.1% achieved good outcomes, and 28.6% had poor outcomes. In the low adherence group, none achieved excellent outcomes, 52% achieved good outcomes, and 48% had poor outcomes (Table 4).

Table 4: Association between Adherence and Outcomes

Adherence Level

Excellent Outcomes (≥75%)

Good Outcomes (50-74%)

Poor Outcomes (<50%)

High (n = 40)

25 (62.5%)

12 (30%)

3 (7.5%)

Moderate (n = 35)

5 (14.3%)

20 (57.1%)

10 (28.6%)

Low (n = 25)

0 (0%)

13 (52%)

12 (48%)

 

 

Figure No:4.Association between Adherence and Clinical Outcomes

 

Table 5: Statistical Analysis

Statistic

Value

Chi-square value (χ²)

38.2

p-value

<0.001

 

Statistical Analysis

The association between treatment adherence and clinical outcomes was statistically significant, as indicated by a chi-square test (χ² = 38.2, p < 0.001) (Table 5).

 

Table 6: Adverse Events

Adverse Event

Number of Patients

Percentage (%)

Mild skin irritation

10

10%

Itching

3

3%

Erythema

2

2%

Total

15

15%

 

Adverse Events

Adverse events were reported in 15 patients (15%), with mild skin irritation being the most common (10 patients), followed by itching (3 patients) and erythema (2 patients). No severe adverse events were observed (Table 6).

Table 7: Patient Satisfaction

Satisfaction Level

Number of Patients

Percentage (%)

Very satisfied (5)

30

30%

Satisfied (4)

40

40%

Neutral (3)

20

20%

Dissatisfied (2)

5

5%

Very dissatisfied (1)

5

5%

Mean satisfaction score

4.1

 

 

 

Patient Satisfaction

Patient satisfaction was assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). The mean satisfaction score was 4.1, with 70% of patients reporting being satisfied or very satisfied with their treatment outcomes (Table 7).

DISCUSSION

This observational study examined the relationship between treatment adherence and clinical outcomes in 100 patients with vitiligo over a 12-month period at Mamata Academy of Medical Sciences, Hyderabad. The findings indicate a significant association between higher adherence to prescribed treatments and better clinical outcomes. Specifically, patients with high adherence (≥80%) showed markedly better repigmentation results compared to those with moderate or low adherence.

Interpretation of Findings

The observed correlation between adherence and clinical outcomes aligns with existing literature, which underscores the importance of consistent treatment adherence in managing chronic conditions like vitiligo. High adherence rates (40% of the sample) were associated with a substantial proportion of patients achieving excellent repigmentation (62.5%), highlighting the efficacy of consistent therapeutic intervention. Conversely, low adherence (<50%) resulted in poor outcomes for nearly half of the patients in that group, underscoring the detrimental impact of non-compliance on treatment efficacy.

 

Several factors could contribute to varying adherence levels, including patient motivation, perceived efficacy of treatment, and the presence of side effects. The study's findings suggest that interventions aimed at improving adherence could significantly enhance treatment outcomes in vitiligo patients. For instance, Kitchen et al9. (2022) emphasized the importance of addressing patient priorities and expectations to improve adherence and outcomes.

 

Previous studies have documented similar findings8, where adherence to topical and systemic treatments significantly influences therapeutic outcomes in vitiligo. Perez-Bootello et al10. (2023) discussed emerging treatments that hold promise for better management of vitiligo. This study expands on existing knowledge by providing specific data on adherence categories and corresponding clinical outcomes, reinforcing the critical role of adherence.

Clinical Implications

The results of this study have important clinical implications. Healthcare providers should emphasize the importance of adherence to patients and consider strategies to enhance compliance, such as patient education, simplified treatment regimens, and regular follow-up appointments. Additionally, addressing potential barriers to adherence, such as managing side effects and providing psychological support, could further improve outcomes. Pasqualoni et al11. (2023) noted the impact of treatment-related adverse events on adherence and the necessity of monitoring and managing these events to maintain compliance.

 

Furthermore, Alharbi14 (2020) identified the risk of depression among vitiligo patients, suggesting that psychological support is crucial for improving treatment adherence and overall quality of life. Integrating mental health support into the treatment plan could help address this issue.

Limitations

This study has several limitations. First, treatment adherence was assessed through self-reports and prescription refill records, which may be subject to recall bias and inaccuracies. Second, the observational nature of the study precludes establishing causality between adherence and outcomes. Third, the study was conducted in a single center, which may limit the generalizability of the findings to broader populations.

Future Research

Future research should focus on longitudinal studies with larger, more diverse populations to validate these findings. Interventional studies designed to test strategies for improving adherence could provide valuable insights into enhancing treatment outcomes. Additionally, exploring the psychosocial aspects of vitiligo and their impact on treatment adherence could inform more holistic management approaches. Kubelis-López et al12. (2021) and Post et al13. (2022) provide valuable insights into new treatments and the use of lasers in vitiligo, which could be explored further in future studies.

CONCLUSION

This study highlights the significant association between treatment adherence and clinical outcomes in patients with vitiligo. High adherence to prescribed treatments correlates with better repigmentation outcomes, underscoring the necessity of promoting adherence among patients. These findings emphasize the need for healthcare providers to implement strategies that support and enhance patient adherence to improve the management of vitiligo effectively.

 

REFERENCES
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  2. .Ali MA, Abou-Taleb DA, Mohamed RR. Treatment adherence and beliefs about medicines among Egyptian vitiligo patients. Dermatol Ther. 2016 Nov;29(6):413-418. doi: 10.1111/dth.12397. Epub 2016 Sep 4. PMID: 27594551.
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  5. Bae JM, Jung HM, Hong BY, Lee JH, Choi WJ, Lee JH, et al. Phototherapy for Vitiligo: A Systematic Review and Meta-analysis. JAMA Dermatol. 2017 Jul 1;153(7):666-674.
  6. Abraham S, Raghavan P. Myths and Facts about Vitiligo: An Epidemiological Study. Indian J Pharm Sci. 2015 Jan-Feb;77(1):8-13. doi: 10.4103/0250-474x.151573. PMID: 25767313; PMCID: PMC4355886.
  7. Wang X, Wu W, Chen J, Li C, Li S. Management of the refractory vitiligo patient: current therapeutic strategies and future options. Front Immunol. 2024 Jan 4;14:1294919. doi: 10.3389/fimmu.2023.1294919. PMID: 38239366; PMCID: PMC10794984.
  8. Kitchen H, Gandhi K, Carmichael C, Wyrwich KW, Lukic T, Al-Zubeidi T, et al. A Qualitative Study to Develop and Evaluate the Content Validity of the Vitiligo Patient Priority Outcome (ViPPO) Measures. Dermatol Ther (Heidelb). 2022 Aug;12(8):1907-1924. doi: 10.1007/s13555-022-00772-4. Epub 2022 Jul 20. PMID: 35857279; PMCID: PMC9297675.
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  10. Perez-Bootello J, Cova-Martin R, Naharro-Rodriguez J, Segurado-Miravalles G. Vitiligo: Pathogenesis and New and Emerging Treatments. Int J Mol Sci. 2023 Dec 9;24(24):17306. doi: 10.3390/ijms242417306. PMID: 38139134; PMCID: PMC10743634.
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