Trends in Hidradenitis Suppurativa Disease Severity and Quality of Life Outcome Measures: Scoping Review

Jalal,

doi:10.2196/27869

Cited by 6 publications

(1 citation statement)

References 65 publications

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“…Given that the development of vitiligo-specifc QoL occurred in the early 2010s, their recent increase in popularity within clinical trials may be more gradual. Similar trends are seen in other dermatologic disease indications, such as hidradenitis suppurativa (HS), in which general dermatology QoL's such as the DLQI were reported most frequently but disease-specifc QoL measures were gaining popularity more recently [18]. Surprisingly, the DLQI and CDLQI were developed in 1994, yet were only routinely used recently in vitiligo clinical trials.…”

Section: Discussionmentioning

confidence: 58%

Quality of Life Assessments Utilized in Vitiligo Clinical Trials

Pathak,

Chandy,

Naini

et al. 2023

Dermatologic Therapy

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Introduction. Vitiligo is an acquired autoimmune disease associated with high psychosocial burden. As novel treatments are being developed in clinical trials, assessing vitiligo disease burden extends beyond physical manifestations. Including quality of life (QoL) measures in vitiligo clinical trials can better capture disease-specific psychosocial concerns and facilitate cross comparisons amongst interventions. Objective. To determine the frequency and types of QoL measures utilized in vitiligo clinical trials and comment on how this has changed longitudinally. Methods. A search of vitiligo clinical trials using clinicaltrials.gov was conducted. Phase 2 and phase 3 trials published in English from January 2000 to July 2023 were eligible for this review. Characteristics of clinical trial parameters were compared to those of non-QoL reporting clinical trials using Pearson’s χ2 tests (or Fisher’s if low n). Results. A total of 60 clinical trials were eligible for this review, of which 40% included a QoL measure in their study design. Phase 3 clinical trials ( p = 0.002), larger (100+ participants) trials ( p = 0.063), U.S. trials ( p = 0.029), and pharmaceutical interventions ( p = 0.022) were more likely to include QoL measures in their design. The number of clinical trials has been increasing over time, with 8 trials from 2000 to 2010, 32 total trials from 2011 to 2020, and 20 trials from 2021 to 2023. The most commonly used QoL measures were the Dermatology Life Quality Index (DLQI, 55.2%), Children's Dermatology Life Quality Index (CDLQI, 13.8%), and Vitiligo-specific quality of life instrument (VitiQoL, 13.8%). Over time, the VitiQoL and CDLQI have been used more frequently. Conclusion. Although vitiligo is associated with high psychological and emotional burden, less than half of vitiligo trials utilize QoL measures. The general dermatology QoL measures, namely the DLQI and CDLQI, are the most commonly used QoL assessments. As the number of clinical trials is increasing, vitiligo-specific questionnaires may better capture unique vitiligo-specific concerns. Standardizing the types of and implementation of QoL questionnaires in clinical trials can aid in assessing outcome measures across clinical trials worldwide and allow for better data interpretation, comparability, and clinical application of results.

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Section: Discussionmentioning

confidence: 58%

Quality of Life Assessments Utilized in Vitiligo Clinical Trials

Pathak,

Chandy,

Naini

et al. 2023

Dermatologic Therapy

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Trends in disease severity and quality of life outcome measures in pemphigus clinical trials: A scoping review

Pathak,

Patel,

Wachuku

et al. 2024

Skin Health and Disease

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Pemphigus represents a spectrum of autoimmune‐mediated blistering diseases associated with high morbidity, mortality and reduced quality of life (QoL). Despite an increase in pemphigus clinical trials, the varied instrument measurements of disease severity and QoL outcomes make comparisons between studies challenging. This study aimed to evaluate trends in the use of disease severity and QoL outcome measurements in pemphigus clinical trials. A review of pemphigus clinical trials was conducted using the PubMed, Embase, Cochrane Reviews and ClinicalTrials.gov databases up until September 2023. Only pemphigus randomized clinical trials that assessed at least one disease severity and/or QoL outcome were included. Overall, 53 clinical trials were eligible for this review. All clinical trials evaluated a disease severity outcome, with the Pemphigus Disease Area Index being the most used validated questionnaire (28.3% of trials) and more popular after 2015 (47.8% of trials since). The autoimmune bullous skin disorder intensity score (7.6%) and visual analogue measurements (7.6%) have fallen out of favour. Most studies now include lab parameters (56.5% of trials after 2015), with anti‐desmoglein 1 and 3 antibody levels (30.2%), immunoglobulins (IgG and/or IgM and IgA) (11.3%), and anti‐drug antibody levels (7.6%) being frequently evaluated. A small portion of trials evaluated QoL (26.5% of studies), with the autoimmune bullous quality of life being the most common (15.1%), however QoL utilization as an outcome measure has been increasing since 2015 (61.1% of trials since). Standardising the use of validated outcome measurements allows for better data interpretation, comparability and clinical application of results.

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