British Journal of Dermatology最新文献

Background: Hidradenitis suppurativa (HS) has unique symptoms and physical features among skin diseases. Patient reported outcome measures (PROMs) agnostic to specific skin diseases may not fully characterise the influence of HS on quality of life (QoL). A HS-specific PROM is needed to capture the impact of HS on QoL in the real-world setting.

Objective: To validate the Hidradenitis Suppurativa Quality of Life Questionnaire (HiSQOL) as a HS-specific PROM by comparing it to the Dermatology Life Quality Index (DLQI) in clinical practice.

Methods: Data were drawn from the Adelphi HS Disease Specific Programme™, a cross-sectional survey of physicians and patients conducted in France, Germany, Italy, Spain, and the United States between November, 2020 and April, 2021. Practicing physicians each provided demographic and clinical data for 5-7 consecutively evaluated HS patients aged at least 10 years receiving any treatment for HS, and an additional 3 patients undergoing biologic treatment; only patients aged at least 18 years were included in this study. Patients completed the DLQI and HiSQOL. Construct validity was assessed by Pearson's correlation between DLQI and HiSQOL scores. The HiSQOL item discrimination was assessed by comparing differences in item responses between the highest and lowest 25% of HiSQOL scores. Multivariable linear regressions assessed relationships between individual PROM item responses and the total score of the other PROM.

Results: In total, 677 patients [mean age of 34.3 (11.3) years; female (57.3%, n=388)] completed both the HiSQOL and DLQI. There was strong correlation between HiSQOL and DLQI total scores (Pearson's correlation 0.87 [95% confidence interval: 0.85-0.89, p<0.001]). The HiSQOL items that had the biggest impact on QoL related to "Embarrassment", "Depression" and "Anxiety", items that also had among the lowest relationship to total DLQI score.

Conclusions: The HiSQOL is a valid tool for assessing QoL in HS patients in the real-world setting. Furthermore, the HiSQOL better captures those aspects of HS that have the highest impact on QoL, including depression and anxiety, which are not captured by the DLQI.

Background: Pruritus, skin pain, and sleep disturbance are a significant burden to individuals with moderate-to-severe atopic dermatitis (AD) and negatively impact quality of life. Fit-for-purpose patient-reported outcome measures (PROMs) that assess AD-related pruritus, skin pain, and sleep disturbance are important for evaluating the effectiveness of new AD treatments.

Objectives: To evaluate content validity of five AD-related PROMs in adolescents and adults with moderate-to-severe AD (the Worst Pruritus Numeric Rating Scale [NRS], the AD Skin Pain NRS; the Sleep Disturbance NRS, the skin pain-specific Patient Global Impression of Change [PGIC], and the skin pain-specific Patient Global Impression of Severity [PGIS]) and to assess patient-reported experience with pruritus, skin pain, and sleep disturbance.

Methods: A qualitative study in adolescents (aged 12-17 years) and adults with moderate-to-severe AD was conducted in two consecutive stages. In each stage, two iterative rounds of individual interviews were conducted by experienced interviewers. All interviews included concept elicitation and cognitive debriefing components. Data were analysed using thematic analysis.

Results: A total of 27 adults and 20 adolescents with moderate-to-severe AD participated in the initial content evaluation (Stage 1) of the Worst Pruritus NRS [1.0] and AD Skin Pain NRS [1.0] (n = 26; 16 adults, 10 adolescents) and in the subsequent content evaluation (Stage 2) of the revised Worst Pruritus NRS [1.1], revised AD Skin Pain NRS [1.1], Sleep Disturbance NRS, skin pain-specific PGIC, and skin pain-specific PGIS (n = 21; 11 adults, 10 adolescents). Results were generally aligned and consistent for both adult and adolescent participants. Additionally, we found that sleep disturbance is relevant and important for evaluation in adults and adolescents with moderate-to-severe AD (Stage 2), while also providing further confirmation of this for pruritus and skin pain (Stages 1 and 2).

Conclusions: Our findings support the content validity of the revised Worst Pruritus NRS [1.1], revised AD Skin Pain NRS [1.1], Sleep Disturbance NRS, skin pain-specific PGIC, and skin pain-specific PGIS in individuals aged ≥12 years with moderate-to-severe AD. Furthermore, the findings support sleep disturbance, skin pain, and pruritus as being relevant and important features for both adolescents and adults with moderate-to-severe AD.