Assessment of quality of life (QoL) in patients with chronic skin diseases: an observational study

Introduction

Psoriasis, vitiligo, and scleroderma are chronic skin conditions that negatively affect patients quality of life (QoL). It has been observed that patients with chronic skin diseases have a lower quality of life than people in the general population.^1–4

Psoriasis is an autoimmune skin disease that causes rashes with itchy and scaly patches on the skin. Psoriasis can range in severity from small localized patches to total body coverage. It is common, chronic, and has no known cure.^5,6 Men and women both experience it equally, and 2–4% of the population is affected by this disease.⁷ Many treatment options are available to manage symptoms.⁸ Patients with psoriasis frequently express feelings of insecurity, helplessness, embarrassment, anger and frustration. Patients with psoriasis tend to avoid or stay away from social gatherings and public areas where rejection may occur. Decreased work productivity and becoming too physically disabled to work have also been reported.^9–11

Patchy skin depigmentation, which can appear on any portion of the body, is a hallmark of vitiligo.¹² It is an autoimmune skin disease, initially the patches are small but they will enlarge over time. The face, hands, and wrists are the most common locations of skin lesions. All skin tones are affected by vitiligo; however, those with dark or black skin may notice it more.^13,14 Worldwide the prevalence is about 2%.¹⁵ Vitiligo lowers self-esteem and causes severe psychological anguish in patients, both of which have a detrimental impact on their quality of life. Skin lesions associated with vitiligo can be observed and cause shame, anxiety and depression.^16–19

Scleroderma is an autoimmune disease that results in hardening and tightening of the skin. Although there is no known cure, available therapies may lessen symptoms.²⁰ Typically, the fingers, hands, feet, and face are the first body areas to be affected. The two warning indications are swelling and itching. Affected skin may become lighter or deeper in colour and appear shiny as a result of tightness.^21,22 Men are less often affected than women and the prevalence of disease is about less than 1% worldwide.²³ It restrict the physical and mental well-being of the patient and contributing to deterioration of quality of life over time.^24–26

Due to the lack of a permanent cure, several treatment methods and unrecognition without appropriate assessment of these chronic skin diseases have profoundly detrimental effects on the health, functioning, and quality of life of those who are affected on all fronts, thus leading to lower quality of life. Additionally, chronic skin diseases are a substantial burden for patients, caretakers, and society.^27–29 It is essential to understand the factors that affect the quality of life of patients with psoriasis, vitiligo, and scleroderma. The prevalence of these chronic skin diseases is coming up to 7%, and the same has been utilized for the calculation of sample size.

The aim of this study is to address issues related to patients quality of life. Assessment of the severity of chronic skin conditions and its effects on the patients quality of life is not easy. The Skindex-29 questionnaire, a skin-specific instrument, will be used to assess the quality of life of patients diagnosed with chronic skin diseases, such as psoriasis, vitiligo, and scleroderma. The Skindex-29 is a more comprehensive, validated, and reliable instrument for investigating and understanding the effects of chronic skin diseases on patients quality of life. Skindex-29 captures the lived experiences of patients through its items on symptoms, emotions, and functioning. It has a longer recall period of 4 weeks and is easy to understand.^30–35

The Skindex-29 has 30 items divided into three categories: symptoms, emotions, and functioning. Each item is rated on a Likert scale ranging from 1 to 5. The following items will be measured in 3 domains:, in symptoms – itching, burning, pain, irritation, bleeding etc.; in emotions – worried, embarrassed, ashamed, frustrated, depressed, etc.; and in functioning – affect, relationships, stay at home, hard to work, sleepless, well-being, etc. Early diagnosis and initiation of a proper course of treatment can significantly enhance the results. QoL instruments such as Skindex-29 provide important information for healthcare professionals, which aids in avoiding the neglect of chronic skin illness. Using the results of Skindex-29, dermatologists can better understand and treat chronic skin diseases, such as psoriasis, vitiligo, and scleroderma.

Protocol

Methods

Selection criteria

Inclusion criteria:

• 1. Either sex (male and female)

• 2. Age ≥ 18 years and ≤ 65 years.

• 3. Patients diagnosed with psoriasis, vitiligo and scleroderma.

• 4. Patients who are willing to comply with the study protocol and complete study assessment tools, such as questionnaires or interviews.

• 5. Willing to give voluntarily informed consent.

• 6. Patients who know English or Hindi or Marathi.

Exclusion criteria:

• 1. Patients who are illiterate.

• 2. Unable to communicate properly.

• 3. Cognitive impairment (having a history of prior or current psychiatric or neuropsychological disorders) which would limit their ability to complete the questionnaires.

• 4. Physically handicapped.

• 5. Pregnant women.

Study procedure & data collection

This is an observational, cross-sectional, questionnaire-based study and will be conducted at the Dermatology Department, Acharya Vinoba Bhave Rural Hospital (AVBRH), Wardha, Maharashtra, after obtaining an approval from the Institutional Ethics Committee (IEC) of the Datta Meghe Institute of Higher Education and Research (DMIHER), Wardha, Maharashtra, India. The study will be conducted in compliance with all regulatory and ethical requirements, and patients details will be kept confidential throughout the study duration.

The duration for enrollment of study patients will be 6 months (26 weeks), and the patients will be enrolled from the Dermatology OPD. Once a suitable patient is found for the study, details about the study and its importance will be explained. The Participant Information Sheet (PIS) will then be given to them to read and understand.

After this, if the patient shows interest in participating in the study, then the Informed Consent Form (ICF) will be given for signature. Once consent is signed, the patient will be screened according to inclusion and exclusion criteria using the Participant Screening Form (PSF) for eligibility.

After screening, if a patient is found to be eligible, he/she will be enrolled in the study and a patient code will be assigned. Approximately 100 patients will be enrolled in this study. Their demographics and other details will be recorded in a Case Report Form (CRF).

A validated questionnaire (i.e. Skindex-29) will be administered through a formal interview to measure the quality of life (QoL) of the patient. Once the interview is completed, the patient will be free to perform routine activities.

All patient data and other study related documents will be stored in the Study Master File (SMF). After total data collection, the data will be analyzed using simple descriptive statistics and other applicable statistical tests. The formulation of the results and conclusion will be drawn on completion of patients recruitment. Refer Figure 1 for study flow chart.

Data assessment & statistical analysis

Data will be assessed:

• 1. To measure the effect of chronic skin diseases (i.e. psoriasis, vitiligo, and scleroderma) and their treatment on patients quality of life (QoL) using the Skindex-29 questionnaire.

• 2. To determine the relationship between QoL and socio-demographics variables.

• 3. To determine the relationship between QoL and disease variables.

Data will be analyzed for emotions, symptoms, and functioning domains using the Skindex-29 questionnaire scaling and scoring guidelines.

Simple descriptive statistics will be applied, such as sum, min, max, average, frequency distribution, and percentage distribution. Graphical representation of data in the form of tabulation, bar charts, and pie charts will be performed using microsoft excel software etc.

Patient enrollment criteria

Patients will be recruited from the Dermatology OPD of Acharya Vinoba Bhave Rural Hospital (AVBRH) according to the inclusion criteria.

It is a patients decision to be part of the study and they will be given a written informed consent document (ICD) to understand. All the details about the study and enough time will be given to decide whether or not to take part in the study.

Patient withdrawal criteria

The Principal Investigator (PI) /Co-Principal investigator may withdraw a patient from the study if the patient:

• • Is in violation of the protocol.

• • Requires early discontinuation for any reason.

• • The investigators will also withdraw all patients if the study is terminated.

• • The patients are free to withdraw from the study at any time upon request.

Sample size calculation

Formula for qualitative variable^7,15,23

$$\mathrm{N}=\frac{{\mathrm{Z}}_{1-\mathrm{\alpha }/2}^{ 2}\times \mathrm{p}\times \left(1-\mathrm{p}\right)}{{\mathrm{d}}^2}$$

Z_1-α/2² = Standard normal variate (at 5% type 1 error (P < 0.05) it is 1.96.

p = Expected proportion in population based on previous or pilot studies i.e. 7% (0.07).

d = Absolute error or precision i.e. 5% (0.05).

Calculation:

$$\text{Sample\hspace{0.17em}size}\left(\mathrm{N}\right)=\frac{{\left(1.96\right)}^2\times \left(0.07\right)\times \left(1-0.07\right)}{{\left(0.05\right)}^2}$$

$$\mathrm{N}=100$$

Hence, the minimum sample size required for the study is 100 patients.

Study flow chart

Figure 1. Study flow chart.

Dissemination

It will be published in an indexed journal.

Study status

The study is yet to begin.

Discussion

In this prospective, cross-sectional study, we are focusing on measuring the effect of chronic skin diseases (i.e. psoriasis, vitiligo, and scleroderma) on patients QoL by using the Skindex-29 questionnaire. Psoriasis, vitiligo, and scleroderma are chronic skin diseases affecting hundreds of people worldwide. According to recent studies, the quality of life of patients suffering from these diseases is impaired. Higher rates of depression, anxiety, psychological well-being, limitations in roles and activities, and poor physical health were observed, which negatively affected overall quality of life.

A study carried out by Sendrasoa et al. on psoriasis reported that symptoms, feelings, and psychological well-being were the most altered dimensions. Disease duration also contributes to poor quality of life.³⁶ Another study by Milcic et al. concluded that stress, disease severity, and a lower level of education are important determinants of poor quality of life in patients with psoriasis.³⁷

In Vora et al.’s study, vitiligo patients' quality of life was evaluated and it was discovered that young patients with the condition had higher levels of depression as well as higher levels of quality of life impairment. The study recommends including mental health consultation and counselling in addition to disease-specific treatment.³⁸ According to a vitiligo study by Bae et al., the participation of visible body parts and a larger afflicted body surface area were consistently linked to a lower quality of life. Additionally, individuals between the ages of 20 and 59 had reduced functioning, and a higher level of education was linked to unfavorable emotional features.³⁹

A study by Lopez-Bastida et al. on scleroderma concluded that patients experience a significant decline in quality of life and significant social expenses.⁴⁰ Muller et al. conducted a cross-sectional study and observed high psychosomatic morbidity and impaired quality of life in patients diagnosed with scleroderma.⁴¹

Based on the results and conclusions of the above studies, we expect similar results in our study population. This study aims to identify the domains in which patients are affected and to find solutions for better management and improvement of patients QoL suffering from psoriasis, vitiligo, and scleroderma.